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    • Premarket Notifications (510(k)s)

    Metadata Updated: July 11, 2025

    Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records.

    Access & Use Information

    Public: This dataset is intended for public access and use. License: See this page for license information.

    Downloads & Resources

    References

    http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm089428.htm

    Dates

    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025
    Data Update Frequency R/P1M

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025
    Publisher U.S. Food and Drug Administration
    Maintainer
    Identifier 142e5da1-24f6-4215-83e5-18a7cd813889
    Data First Published 2021-02-25
    Data Last Modified 2013-11-01
    Category FDA
    Public Access Level public
    Data Update Frequency R/P1M
    Bureau Code 009:10
    Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
    Metadata Catalog ID https://healthdata.gov/data.json
    Schema Version https://project-open-data.cio.gov/v1.1/schema
    Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
    Harvest Object Id af903402-40ed-40ac-9888-1916cc8cd90b
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
    License http://opendefinition.org/licenses/odc-odbl/
    Program Code 009:005
    Related Documents http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm089428.htm
    Source Datajson Identifier True
    Source Hash dc29ff81032ba5e7405a6729c9a7fedb1524246c38e51c6ace2a955b6d1f939a
    Source Schema Version 1.1
    Temporal 1976-01-01/2013-12-31

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