Halyard 76827
Halyard 76827 is a Class II device made by O&M Halyard Inc., cleared under FDA 510(k) K974068 on 22 Dec 1997 and listed in FDA GUDID since 18 Nov 2020 (UDI-DI 20680651768272), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20680651768272 | Date18 Nov 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK974068 | Date22 Dec 1997 | StatusActive |
Official records
- AccessGUDID record 20680651768272
- FDA 510(k) database K974068
Across registries
- FDA 510(k) K974068 decided 22 Dec 1997 Active
- FDA GUDID UDI-DI 20680651768272 listed 18 Nov 2020 Listed
Recalls
-
- Ongoing Z-2626-2023
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Timeline
- Cleared FDA 510(k) K974068
- Listed FDA GUDID 20680651768272
- Recall initiated FDA recalls Z-2626-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Halyard
- Generic name
- Surgical/medical respirator, non-antimicrobial, single-use
- Model / Ref / Catalog
- 76827
- Primary DI / UDI-DI
- 20680651768272
- 510(k) Number
- FDA product code
- MSH
- GMDN term
- Surgical/medical respirator, non-antimicrobial, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution