Instrusafe In-2020-8284
Instrusafe In-2020-8284 is a Class II device made by Summit Medical, LLC, cleared under FDA 510(k) K210836 on 30 Nov 2021 (8 earlier submissions) and listed in FDA GUDID since 14 Oct 2026 (UDI-DI 00385640095068), active as of 2 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00385640095068 | Date14 Oct 2026 | StatusListed |
| United States | FDA 510(k) | NumberK210836 | Date30 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 00385640095068
- FDA 510(k) database K210836
- FDA 510(k) database K151166
- FDA 510(k) database K150540
- FDA 510(k) database K142768
- FDA 510(k) database K142630
- FDA 510(k) database K141513
- FDA 510(k) database K140289
- FDA 510(k) database K133015
- FDA 510(k) database K051157
Across registries
- FDA 510(k) K210836 decided 30 Nov 2021 Active
- FDA GUDID UDI-DI 00385640095068 listed 14 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K051157
- Cleared FDA 510(k) K133015
- Cleared FDA 510(k) K140289
- Cleared FDA 510(k) K141513
- Cleared FDA 510(k) K142630
- Cleared FDA 510(k) K142768
- Cleared FDA 510(k) K150540
- Cleared FDA 510(k) K151166
- Cleared FDA 510(k) K210836
- Listed FDA GUDID 00385640095068
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Instrusafe
- Generic name
- Instrument tray, reusable
- Model / reference
- IN-2020-8284
- Primary DI / UDI-DI
- 00385640095068
- FDA product code
- KCT
- GMDN term
- Instrument tray, reusable
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution