SoftCheck BP Cuffs
by Statcorp Medical 183 variants
SoftCheck BP Cuffs (3009167-058) is a Class II device made by Statcorp Medical, cleared under FDA 510(k) K940214 on 22 Feb 1994 and listed in FDA GUDID since 7 Jun 2024 (UDI-DI 10841522130649), active as of 23 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 | Number10841522130649 | Date7 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK940214 | Date22 Feb 1994 | StatusActive |
Official records
- AccessGUDID record 10841522130649
- FDA 510(k) database K940214
Across registries
- FDA 510(k) K940214 decided 22 Feb 1994 Active
- FDA GUDID UDI-DI 10841522130649 listed 7 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K940214
- Listed FDA GUDID 10841522130649
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- Withdrawn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 / Ref / Catalog
- SoftCheck BP Cuffs, 3009167-058
- Primary DI / UDI-DI
- 10841522130649
- 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
Other devices filed under FDA product code DXQ (blood pressure cuff).
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- Disposable NIBP Cuff by SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
- BLOOD PRESSURE CUFFS by Vital Signs, Inc.