Orbit-K 98-0061-23
Orbit-K 98-0061-23 is a Class II device made by SunTech Medical, Inc, cleared under FDA 510(k) K122401 on 2 Nov 2012 and listed in FDA GUDID since 2 Mar 2023 (UDI-DI 10840935110040), 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 | Number10840935110040 | Date2 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122401 | Date2 Nov 2012 | StatusActive |
Official records
- AccessGUDID record 10840935110040
- FDA 510(k) database K122401
Across registries
- FDA 510(k) K122401 decided 2 Nov 2012 Active
- FDA GUDID UDI-DI 10840935110040 listed 2 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K122401
- Listed FDA GUDID 10840935110040
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Orbit-K
- Generic name
- Blood pressure cuff, reusable
- Model / reference
- 98-0061-23
- Primary DI / UDI-DI
- 10840935110040
- 510(k) Number
- FDA product code
- DXN
- GMDN term
- Blood pressure cuff, reusable
- Device class
- Class II
- Regulation number
- 870.1130
- GUDID distribution status
- In Commercial Distribution