Kbmed SBCN23-1H
Kbmed SBCN23-1H is a blood collection set (FDA Class II; FDA product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection) made by KB Medical (group), Inc., cleared under FDA 510(k) K232881 on 22 Dec 2023 and listed in FDA GUDID since 21 May 2025 (UDI-DI 00850016172372), 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 | Number00850016172372 | Date21 May 2025 | StatusListed |
| United States | FDA 510(k) | NumberK232881 | Date22 Dec 2023 | StatusActive |
Official records
- AccessGUDID record 00850016172372
- FDA 510(k) database K232881
Across registries
- FDA 510(k) K232881 decided 22 Dec 2023 Active
- FDA GUDID UDI-DI 00850016172372 listed 21 May 2025 Listed
Timeline
- Cleared FDA 510(k) K232881
- Listed FDA GUDID 00850016172372
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kbmed
- Generic name
- Blood collection set, invasive
- Model / reference
- SBCN23-1H
- Description
- Safety blood collection set with pre-attached holder, 23G*3/4" with 12" tubing
- Primary DI / UDI-DI
- 00850016172372
- 510(k) Number
- FDA product code
- JKA
- GMDN term
- Blood collection set, invasive
- Device class
- Class II
- Regulation number
- 862.1675
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Blood collection set, invasive.