Topcare 52-50K
Topcare 52-50K is a Class II device made by Topco Associates, LLC, cleared under FDA 510(k) K082641 on 10 Nov 2008 and listed in FDA GUDID since 4 Aug 2020 (UDI-DI 00036800023420), 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 | Number00036800023420 | Date4 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082641 | Date10 Nov 2008 | StatusActive |
Official records
- AccessGUDID record 00036800023420
- FDA 510(k) database K082641
Across registries
- FDA 510(k) K082641 decided 10 Nov 2008 Active
- FDA GUDID UDI-DI 00036800023420 listed 4 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K082641
- Listed FDA GUDID 00036800023420
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Topcare
- Generic name
- Pulse oximeter probe, reusable
- Model / reference
- 52-50K
- Primary DI / UDI-DI
- 00036800023420
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Pulse oximeter probe, reusable
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Pulse oximeter probe, reusable.