SoftCheck ST4250FL
SoftCheck ST4250FL is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K940214 on 22 Feb 1994 and listed in FDA GUDID since 30 Aug 2019 (UDI-DI 00858293006656), active as of 22 Oct 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 | Number00858293006656 | Date30 Aug 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK940214 | Date22 Feb 1994 | StatusActive |
Official records
- AccessGUDID record 00858293006656
- FDA 510(k) database K940214
Across registries
- FDA 510(k) K940214 decided 22 Feb 1994 Active
- FDA GUDID UDI-DI 00858293006656 listed 30 Aug 2019 Listed
Timeline
- Cleared FDA 510(k) K940214
- Listed FDA GUDID 00858293006656
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SoftCheck
- Generic name
- Blood pressure cuff, single-use
- Model / reference
- ST4250FL
- Primary DI / UDI-DI
- 00858293006656
- 510(k) Number
- FDA product code
- DXQ
- GMDN term
- Blood pressure cuff, single-use
- Device class
- Class II
- Regulation number
- 870.1120
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Blood pressure cuff, single-use.