Published May 18, 2026
| Version v1.0
Dataset
Open
FDA 510(k) Medical Device Clearance Dataset (1980-2025)
Authors/Creators
Description
Structured dataset of 166,200 FDA 510(k) medical device clearance records spanning 1980-2025.
The dataset is derived from publicly available FDA CDRH flat files and normalized for regulatory research, machine learning, and medical device analytics.
It includes device metadata, manufacturer information, classification codes, review panels, and clearance outcomes.
This dataset is maintained as part of 510kDatabase.net and is continuously updated following FDA monthly releases.
The dataset is derived from U.S. FDA public 510(k) records:
https://www.fda.gov/medical-devices/510k-clearances/downloadable-510k-files
Project website:
https://www.510kdatabase.net
Files
fda-510k-medical-device-clearance-dataset-1980-2025-v1.pdf
Files
(16.7 kB)
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Additional details
Related works
- Cites
- Journal article: 10.1371/journal.pone.0257669 (DOI)
- Is derived from
- Software: https://www.510kdatabase.net (URL)
- Is supplemented by
- Other: https://www.fda.gov/medical-devices/510k-clearances/downloadable-510k-files (URL)
- References
- Other: https://clinicaltrials.gov (URL)
Dates
- Collected
-
2026-05-18
References
- [1] U.S. Food and Drug Administration. (accessed 2026). Downloadable 510(k) Files. Center for Devices and Radiological Health. https://www.fda.gov/medical-devices/510k-clearances/downloadable-510k-files
- [2] U.S. Food and Drug Administration. (accessed 2026). 510(k) Premarket Notification. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
- [3] U.S. Food and Drug Administration. (accessed 2026). Device Classification Panels. https://www.fda.gov/medical-devices/classify-your-medical-device/device-classification-panels
- [4] U.S. National Library of Medicine. (accessed 2026). ClinicalTrials.gov. https://clinicaltrials.gov
- [5] Hwang, T.J., Sokolov, E., Franklin, J.M., & Kesselheim, A.S. (2021). Mapping the genealogy of medical device predicates in the United States. PLOS ONE, 16(10), e0258153. https://doi.org/10.1371/journal.pone.0257669
- [6] Dubin, J.R., et al. (2021). Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017. JAMA Network Open, 4(5), e217274. https://doi.org/10.1001/jamanetworkopen.2021.7274
- [7] 510kDatabase Research Team. (2026). 510kDatabase.net - Independent FDA 510(k) Regulatory Intelligence Platform. https://www.510kdatabase.net