Premarket Notifications (510(k)s)

Metadata Updated: March 16, 2021

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 March 16, 2021
Data Update Frequency R/P1M

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date March 16, 2021
Publisher U.S. Food and Drug Administration
Unique Identifier Unknown
Maintainer
Identifier 142e5da1-24f6-4215-83e5-18a7cd813889
Data First Published 2021-02-25
Data Last Modified 2013-11-01
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 6064cbc2-1f2e-4527-88ad-81d549adfdf7
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 e76ea899896e945340fe16a141f4a1997a963420
Source Schema Version 1.1
Temporal 1976-01-01/2013-12-31

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