Disposable Cuff 98-0399-5K
Disposable Cuff 98-0399-5K is a Class II device made by SunTech Medical, Inc, cleared under FDA 510(k) K080854 on 20 Oct 2008 and listed in FDA GUDID since 7 Dec 2018 (UDI-DI 10840935108207), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10840935108207 | Date7 Dec 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080854 | Date20 Oct 2008 | StatusActive |
Official records
- AccessGUDID record 10840935108207
- FDA 510(k) database K080854
Across registries
- FDA 510(k) K080854 decided 20 Oct 2008 Active
- FDA GUDID UDI-DI 10840935108207 listed 7 Dec 2018 Listed
Recalls
-
- Terminated Z-2277-2019
Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.
Timeline
- Cleared FDA 510(k) K080854
- Listed FDA GUDID 10840935108207
- Recall initiated FDA recalls Z-2277-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Disposable Cuff
- Generic name
- Blood pressure cuff, reusable
- Model / reference
- 98-0399-5K
- Primary DI / UDI-DI
- 10840935108207
- 510(k) Number
- FDA product code
- DXQ
- GMDN term
- Blood pressure cuff, reusable
- Device class
- Class II
- Regulation number
- 870.1120
- GUDID distribution status
- In Commercial Distribution