510k Database -
Free Searchable FDA 510(k) Device Database
510k Database indexes 4,872 FDA 510(k) medical device clearances from 1976 to the present. Search any device by K-number, manufacturer name or product type.
510(k) Devices by Medical Specialty
Browse FDA 510(k) clearances organized by the 20 FDA review panels, from Anesthesiology to Toxicology.
Ventilators, anesthesia machines, breathing circuits and airway devices.
Catheters, stents, pacemakers, monitors and cardiovascular surgical devices.
In vitro diagnostic reagents, analyzers and clinical chemistry test systems.
Dental implants, drills, crowns, imaging systems and restorative materials.
Hearing aids, cochlear implants, ENT surgical instruments and endoscopes.
Endoscopes, stents, urology devices and gastrointestinal diagnostic tools.
Surgical lasers, electrosurgical units, laparoscopic tools and wound care.
Infusion pumps, IV sets, syringes and general-purpose hospital equipment.
Blood analyzers, cell counters and coagulation diagnostic systems.
Immunoassay systems, allergy tests and immunological diagnostic devices.
Culture systems, microbial identification and infectious disease test kits.
EEG systems, neurostimulators, robotic surgical navigation and neuromonitoring.
Fetal monitors, breast pumps, IUDs and gynecological surgical instruments.
Contact lenses, IOLs, ophthalmic lasers and retinal imaging systems.
Joint implants, surgical navigation, bone fixation and robotic surgery systems.
Tissue staining, automated histology and anatomical pathology instruments.
Ultrasound therapy, electrotherapy, rehabilitation and diagnostic devices.
CT, MRI, X-ray, ultrasound imaging systems and radiation therapy devices.
Drug screening assays, therapeutic drug monitoring and toxicology panels.
Latest FDA 510(k) Clearances
Most recently cleared medical devices. Updated automatically each month from FDA records.
Top Medical Device Manufacturers
Companies with the most FDA 510(k) submissions in the database.
What is 510k Database?
510k Database is a free, independent search tool for FDA 510(k) premarket notification records. It is not affiliated with the FDA.
- Data sourced directly from the FDA 510(k) downloadable files.
- 174,000+ records from May 1976 to the present.
- Updated automatically on the 5th of each month.
- Device classification enriched via the openFDA Device Classification API.
- All FDA data is in the public domain (17 U.S.C. § 105).
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.
Search the FDA 510(k) Database
510k Database is a free, independent searchable database of FDA 510(k) premarket notification clearances. 174,000+ records from 1976 to present.
Search all 510(k) clearances