Free Searchable FDA 510(k) Database
An independent FDA 510(k) intelligence platform built for regulatory professionals and medical device researchers. Search 174,000+ clearances, track manufacturers, explore linked clinical trials and follow monthly market activity - all from official FDA data.
What you can do with this database
510k Database goes beyond raw FDA records - it structures clearance data into actionable regulatory intelligence for industry professionals.
Compare clearance speed across manufacturers
Identify which companies consistently achieve fast FDA reviews and which categories show extended review cycles - by panel, product code or year.
Search manufacturersIdentify predicate strategies in AI medical devices
Explore how AI imaging and SaMD companies navigate the 510(k) pathway, which product codes they target and how review times compare to traditional devices.
Explore AI clearancesBenchmark review times by FDA panel
Compare average FDA review durations across the 20 specialty panels. Understand whether a submission's review time is typical, fast or delayed for its category.
View monthly reportsTrack regulatory patterns by product code
Each product code groups devices with comparable regulatory requirements. Browse 339 categories to map the competitive landscape within a specific device classification.
Browse product codesResearch regulatory consultants
Identify which consulting firms manage 510(k) submissions for specific device categories - and trace their clearance history, review timelines and FDA panel specialization across submissions.
Search by consultantMonitor manufacturer regulatory activity
Track clearance velocity, category concentration and clearance rates for 4,971+ manufacturers - from global medtech companies to emerging device startups.
Browse manufacturersMonthly FDA 510(k) Clearance Analysis
Each month, we analyze all FDA 510(k) clearances from the previous month, breaking down totals by medical specialty, average review time, and most active manufacturers. Reports are published on the 5th of each month directly from official FDA data. Browse all monthly reports.
FDA 510(k) Regulatory Intelligence - Beyond the Official Database
Each device record is enriched with the regulatory consulting firm that managed the submission, linked clinical trial data from ClinicalTrials.gov, and submission flags including third-party review, combination product status and PCCP authorization - intelligence not available in the FDA's downloadable files.
Benchmark review timelines across 20 FDA panels - median 129 days for cleared devices versus 337 days for denied submissions - identify predicate devices, track manufacturer clearance velocity, and analyze AI and SaMD regulatory pathways across 174,000+ clearances.
Ventilators, anesthesia delivery systems and breathing circuits used in operating rooms and ICUs. Includes airway management devices, patient warming systems and perioperative monitoring equipment. One of the more predictable FDA panels: average clearance of 139 days, with one of the lowest denial rates across all device categories. 9 submissions include linked clinical trial evidence.
Catheters, stents, pacemakers and electrophysiology systems used in interventional cardiology and cardiac surgery. Includes hemodynamic monitoring, vascular grafts and heart failure management devices. The panel with the highest number of linked clinical trials across all FDA categories - 38 submissions reference registered ClinicalTrials.gov studies, reflecting the clinical evidence demands of this high-stakes specialty. Average clearance: 124 days.
In vitro diagnostic analyzers and reagent systems used in clinical laboratories for blood chemistry, metabolite testing and point-of-care diagnostics. The fastest-clearing major FDA panel, averaging just 88 days to decision - significantly below the cross-panel median. 15 submissions carry linked clinical trial evidence from ClinicalTrials.gov.
Implant systems, intraoral scanners and CAD/CAM restorative platforms used across general dentistry and oral surgery. Includes AI-powered diagnostic tools, orthodontic devices and digital workflow systems. The lowest denial rate of all 20 FDA review panels - fewer than 1 in 1,000 dental 510(k) submissions results in a Not Substantially Equivalent determination. Average review: 127 days.
Cochlear implants, ENT endoscopes and surgical navigation systems used in otolaryngology practices and ENT surgery. Includes hearing diagnostics, balloon sinuplasty and airway management tools. Among the faster FDA panels for clearance decisions, averaging 88 days - on par with Chemistry. Low overall submission volume relative to surgical panels.
Endoscopes, GI stents and urological devices used in gastroenterology suites, urology clinics and minimally invasive surgery. Includes colonoscopy systems, lithotripsy and bladder management devices. One of the panels with the highest denial counts among mid-size categories - 47 Not Substantially Equivalent decisions on record. Average clearance: 129 days. 12 submissions with linked clinical trials.
Electrosurgical units, surgical lasers and laparoscopic instrument systems used across general surgery, plastic surgery and wound care. Includes energy-based tissue management, liposuction and minimally invasive closure devices. One of the three largest FDA panels with over 18,100 clearances. 24 submissions carry linked clinical trial evidence - the second highest among all panels. Average clearance: 114 days.
Infusion pumps, patient monitoring systems and vascular access devices used across all hospital departments. The broadest device category, covering ICU equipment, surgical supplies and general clinical infrastructure. One of the three highest-volume FDA panels with over 17,700 clearances. Average review: 128 days, with a denial rate under 0.15%.
Hematology analyzers, cell counters and coagulation systems used in hospital labs and transfusion medicine. Critical instruments for complete blood count, hemostasis testing and blood banking workflows. A stable regulatory pathway with a very low denial rate and average clearance of 112 days. 2 submissions carry linked clinical trial data.
Immunoassay platforms and autoimmune test systems used in clinical immunology labs and allergy clinics. Includes cytokine assays, protein quantification and transplant compatibility testing. Average clearance of 104 days and a low denial rate. A relatively straightforward predicate-based pathway with no linked clinical trials currently recorded in 510(k) submissions.
Molecular diagnostic systems and genetic analysis platforms used in clinical genetics labs and precision medicine programs. Includes chromosomal analysis tools and inherited disease screening devices. The most challenging FDA regulatory pathway by far: with only 19 total submissions on record, 8 have been denied - a 42% denial rate, the highest of any panel. Average review time across all outcomes exceeds 399 days, signalling exceptional regulatory complexity in this emerging category.
Rapid diagnostic test kits, culture systems and molecular identification platforms used in hospital microbiology labs and infection control. Key tools for sepsis workup, antimicrobial stewardship and outbreak surveillance. The panel with the highest denial rate among all major FDA categories - 62 Not Substantially Equivalent decisions on record. Predicate selection and submission strategy are particularly critical here. Average clearance: 100 days.
Neurostimulators, EEG systems and AI-powered surgical navigation used in neurology departments and neurosurgery. Includes deep brain stimulation, epilepsy monitoring and robotic-assisted cranial procedures. The panel with the highest concentration of denials for AI and SaMD submissions - 54 Not Substantially Equivalent decisions on record. Average clearance of 146 days and 19 submissions with linked clinical trial evidence from ClinicalTrials.gov.
Fetal monitoring systems, endometrial ablation devices and minimally invasive surgical tools used in obstetrics, gynecology and reproductive medicine. Includes diagnostic ultrasound and IUD delivery systems. The slowest-clearing panel for approved devices across all 20 FDA categories, averaging 160 days to decision - a key timeline benchmark for manufacturers planning submissions in this specialty. 6 submissions carry linked clinical trial data.
Intraocular lenses, ophthalmic lasers and retinal imaging systems used in ophthalmology clinics and eye surgery centers. Covers cataract surgery platforms, glaucoma management and AI-based retinal diagnostics. The second highest clinical trial density of all panels - 25 submissions carry linked ClinicalTrials.gov evidence, reflecting the clinical data requirements of implantable and laser devices. Average clearance: 108 days.
Joint replacement systems, spinal implants and robotic surgical navigation used in orthopedic surgery and sports medicine. The largest FDA device category by submission volume, covering hip, knee, spine and extremity reconstruction. Despite its scale, it maintains one of the lowest denial rates across all panels - under 0.1% of 17,700+ submissions. Average clearance: 122 days.
Automated histology systems, digital pathology platforms and tissue staining instruments used in anatomical pathology labs and oncology workflows. Includes slide scanners and AI-assisted tumor grading tools. A small but demanding panel: the fastest average clearance when approved at just 74 days, but with a denial rate exceeding 2% - the highest of any panel except Medical Genetics. Thorough predicate selection is essential.
Electrotherapy systems, therapeutic ultrasound and rehabilitation equipment used in physical therapy clinics and sports medicine. Includes neuromuscular electrical stimulation, traction and diagnostic ultrasound for musculoskeletal assessment. A reliable clearance pathway with a very low denial rate and average review of 115 days. 3 submissions carry linked clinical trial evidence.
CT, MRI, X-ray systems and AI-powered image analysis software used in hospital radiology departments and teleradiology platforms. The fastest-growing FDA panel, driven by AI imaging clearances under product code QIH. Despite rapid growth in AI submissions, it maintains a low denial rate and an average clearance of 106 days - making it one of the more efficient panels for innovative device pathways.
Immunoassay drug screening systems and therapeutic drug monitoring platforms used in emergency medicine, addiction treatment and forensic labs. Covers point-of-care and laboratory-based substance detection assays. One of the fastest-clearing panels in the FDA portfolio, averaging just 86 days to clearance decision - among the lowest of all 20 review panels - with a low denial rate and well-established predicate landscape.
Medical Device Intelligence by Technology Type
Explore FDA-cleared devices by clinical application and technology category.
Recently Cleared Medical Devices - Market Activity
Track new device entries across specialties. Updated monthly from official FDA clearance records.
Top Medical Device Manufacturers
Companies with the most FDA 510(k) submissions in the database.
Built for medical device industry professionals
510k Database is used across the medical device and healthcare industry for regulatory research, competitive intelligence and market analysis.
Regulatory Affairs Teams
Find predicate devices, benchmark review timelines and track competitor submissions across your device category.
MedTech Startups
Map predicate strategies used by cleared AI and SaMD companies. Understand clearance pathways before starting your 510(k).
Healthcare Investors
Use clearance velocity and regulatory patterns as signals for market entry risk, competitive intensity and product pipeline activity.
Regulatory Consultants
Benchmark clearance timelines, identify pathway trends and prepare market context for 510(k) submissions and strategic planning.
What is 510k Database?
510k Database is a free, independent regulatory intelligence platform for FDA 510(k) premarket notification records. It is not affiliated with the FDA.
- 174,883 devices mapped into regulatory intelligence clusters across 4,754 product codes and 20 FDA review panels.
- Data sourced directly from the FDA 510(k) downloadable files and enriched with classification metadata.
- Updated automatically on the 5th of each month from official FDA records.
- Each device record includes regulatory pathway interpretation, review time benchmarking and manufacturer clearance profiles.
- Selected records include the regulatory consultant who managed the submission - intelligence not available in the FDA's downloadable files.
- When a 510(k) references a registered clinical trial, the device record links to the full study data from ClinicalTrials.gov - including enrollment, outcomes and publication status.
How is this different from FDA.gov?
The FDA's own search at accessdata.fda.gov lets you look up individual submissions by K-number. 510k Database goes further: you can search across 174,000+ records simultaneously, filter by specialty, year, review time or clearance decision, and browse manufacturer histories with submission counts and clearance rates. Device classifications are enriched with product codes, CFR regulation numbers and panel assignments not surfaced by the FDA's default interface.
Monthly clearance intelligence
Beyond the searchable database, we publish a monthly analysis of all FDA 510(k) clearances from the previous month. Each report covers total clearances by specialty, average FDA review time, and the most active manufacturers. These reports are used by regulatory teams to monitor market activity, identify competitors entering new device categories, and track how review times evolve across specialties over time.
What is a 510(k) clearance?
A 510(k) is a premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. Required for most Class I and Class II devices sold in the U.S.
Who uses this 510(k) database?
Regulatory affairs professionals, medical device manufacturers, healthcare procurement teams and researchers use this database to verify device clearances, find predicate devices and track competitor submissions.
How often is the data updated?
The FDA publishes updated 510(k) records on the 5th of each month. This database syncs automatically within 24 hours of each FDA release.
What do "cleared" and "not cleared" mean?
Cleared (SESE) means the FDA determined the device is substantially equivalent and may be marketed in the U.S. Not cleared (DENG) means the FDA found the device is not substantially equivalent to any predicate.
How do I search the FDA 510(k) database?
Use the search bar at the top of this page. You can search by device name, manufacturer name, or K-number (e.g. K243854). You can also browse by medical specialty or filter by decision, year, or product code. Results link directly to the full device record and the official FDA submission.
Is 510(k) clearance the same as FDA approval?
No. 510(k) clearance means the FDA determined a device is substantially equivalent to a legally marketed predicate device. It is used for most Class I and Class II devices. FDA approval (PMA - Premarket Approval) is a separate, more rigorous process required for high-risk Class III devices, based on clinical trial evidence of safety and effectiveness. It is legally incorrect to describe a 510(k)-cleared device as "FDA approved."
Are FDA 510(k) submissions public?
Yes, partially. The FDA publishes the decision, device name, applicant, product code, and a summary of safety and effectiveness for each 510(k) within 30 days of the decision. Detailed technical and proprietary information is withheld. Full submissions can be requested via FOIA, though they are often heavily redacted. All records in this database are sourced from the FDA 510(k) public files, which are in the public domain.
What are the three types of 510(k)?
The FDA recognizes three types of 510(k) submission. A Traditional 510(k) is the standard path, requiring full substantial equivalence documentation. A Special 510(k) is a streamlined path for modifications to a manufacturer's own legally marketed device. An Abbreviated 510(k) relies on FDA-recognized standards or special controls to demonstrate substantial equivalence, simplifying the submission.
Does a 510(k) clearance expire?
No, a 510(k) clearance does not have an expiration date. However, if a manufacturer makes a significant change to a cleared device - in design, materials, intended use, or manufacturing - a new 510(k) submission may be required before marketing the modified device. The FDA provides guidance on when changes require a new submission.
What additional information do device records include?
Beyond the core FDA clearance data, individual device records are progressively enriched with information from official public sources. This includes the regulatory consultant who managed the 510(k) submission - a signal useful for competitive intelligence - as well as flags for third-party review, combination product status, and Predetermined Change Control Plan (PCCP) authorization, relevant for AI and software-based devices. When a 510(k) references a registered clinical trial, the device record links to the full study data from ClinicalTrials.gov, including design, enrollment, outcomes and publication status. Not all records have been enriched - coverage expands over time.
Is this an official FDA database?
No. 510k Database is an independent, free-to-use search tool built on top of the FDA's publicly available 510(k) data files. It is not affiliated with or endorsed by the U.S. Food and Drug Administration. The official FDA 510(k) search tool is available at accessdata.fda.gov. This database uses the same underlying public data but offers enhanced search, manufacturer profiles, product code browsing, and monthly clearance analysis not available on the FDA's own interface. Learn more on the About page.
How do I find a predicate device for a 510(k) submission?
Search by device type, product code, or manufacturer to find cleared devices that could serve as predicates. Use the advanced search to filter by FDA review panel, decision year, or product code and narrow results to your device category. Each device record links directly to the full submission on accessdata.fda.gov where predicate device information is documented. You can also browse by product code category to find all cleared devices within a specific classification, or explore devices by medical specialty.
Search the FDA 510(k) Database
Updated monthly from FDA records. Browse clearance reports by specialty, review time and manufacturer - or search any of the 174,000+ devices directly.
Search all 510(k) clearances