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Premarket Notifications (510(k)s)
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. The database is updated once a week.
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View Parent Record: Deviceclearance API
Complete Metadata
| @type | Dataset |
|---|---|
| accessRights | public |
| contactPoint |
[ { "fn": "FDA Governance Team", "@type": "Kind", "hasEmail": "mailto:uig@fda.hhs.gov" } ] |
| description | 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. The database is updated once a week. |
| distribution |
[ { "@type": "Distribution", "title": "Premarket Notifications (510(k)s)", "accessURL": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm", "accessService": [ { "@type": "DataService", "title": "Deviceclearance API", "publisher": { "name": "FDA", "@type": "Organization" }, "endpointURL": [ "https://api.fda.gov/device/510k" ], "contactPoint": [ { "fn": "open FDA", "@type": "Kind", "hasEmail": "mailto:open@fda.hhs.gov" } ], "endpointDescription": [ "https://api.fda.gov/device/510k.json" ] } ], "useRestriction": [ { "@type": "UseRestriction", "restrictionStatus": "unrestricted" } ] } ] |
| identifier | 0014-FDA-CDRH-PB-I-202608 |
| inventoried | 2026-09-27 |
| isPartOf | api.fda.gov |
| keyword |
[ "Devices/ Pre-Market/ Notification" ] |
| publisher |
{ "name": "Center for Devices and Radiological Health (CDRH)", "@type": "Organization", "subOrganizationOf": [ { "name": "Food and Drug Administration (FDA)", "@type": "Organization", "subOrganizationOf": [ { "name": "U.S. Department of Health and Human Services", "@type": "Organization" } ] } ] } |
| status | Candidate |
| theme |
[ { "@type": "Concept", "prefLabel": "Devices" } ] |
| title | Premarket Notifications (510(k)s) |
