FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

FDA 510(k) Regulatory Intelligence - Current Landscape
174,883
Devices indexed
1976 – present
130d
Median review time
Class II devices, 2023–2025
100%
Historical clearance rate
SESE decisions vs total
Most active specialty
By submission volume
3,147
New clearances (12 months)
Rolling 12-month window
474
Not cleared (DENG)
Avg 338d to denial · Browse →
FDA 510(k) Decision Landscape Across 174,883 submissions, 1976–present
✓ ~99.7% of 510(k) submissions are ultimately cleared - substantially equivalent to a legally marketed predicate device.
⏱ Cleared devices average 130 days from submission to decision under traditional 510(k) review.
✗ Denied submissions average 338 days to decision - nearly 3× longer than cleared devices - before receiving a Not Substantially Equivalent ruling.
◎ Only 474 devices have been denied across 50 years of 510(k) history. Browse denials →

Trending regulatory searches

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How regulatory professionals use this database

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Find predicate devices

Identify cleared devices substantially equivalent to yours. Filter by product code, specialty and decision year to narrow your predicate strategy.

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Benchmark review timelines

Compare FDA review durations across manufacturers and categories. Understand whether a timeline is typical, fast, or delayed for its panel.

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Track competitor submissions

Monitor clearance velocity and category activity for any manufacturer. Detect new entries in your device classification as they happen.

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Analyze AI & SaMD pathways

Explore how AI imaging and SaMD companies navigate 510(k). Identify which product codes they target and how review times compare to traditional devices.

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Map competitive landscapes

Browse 339 product code categories to understand which companies dominate a device classification and which remain under-served.

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Research clinical trial evidence

For devices with linked clinical trials, explore study design, enrollment, outcomes and whether results have been published - directly from ClinicalTrials.gov.

What makes 510k Database unique

Linked clinical trials

When a 510(k) references a registered clinical trial, we surface the full study data from ClinicalTrials.gov — enrollment, outcomes, design, and whether results have been published.

Browse devices with clinical trials →
Regulatory consultant data

Each enriched device record identifies the regulatory consulting firm that managed the 510(k) submission — intelligence not available in the FDA's downloadable files or any other free platform.

Try searching by consultant →
Submission flags

Device records include third-party review status, combination product designation, and PCCP authorization — the AI/SaMD pathway signal increasingly relevant for software-based medical devices.

Explore AI device clearances →

Search tips

By product code
Try QIH, OLO, MBI — each maps to a specific device classification
By K-number
Enter the exact clearance number, e.g. K243854
By manufacturer
Search Abbott, Medtronic, or any company name
By device type
Try clinical terms like "glucose meter", "pacemaker lead" or "CT scanner"
By regulatory consultant
Search a consulting firm name, e.g. Bentley Biomedical, to find all submissions they have managed
Or browse by clinical specialty:
Cardiovascular Orthopedic Radiology Microbiology Chemistry Surgery Neurology Dental

510k Database transforms FDA clearance records into actionable regulatory intelligence — enriched with regulatory consultant data, linked clinical trials from ClinicalTrials.gov, and submission flags for device manufacturers, regulatory affairs teams and healthcare investors. About this platform →