Nellcor 10004954
by Covidien LP
Nellcor 10004954 is a Class II device made by Covidien LP, cleared under FDA 510(k) K012891 on 7 Mar 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521581746), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521581746 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012891 | Date7 Mar 2002 | StatusActive |
Official records
- AccessGUDID record 10884521581746
- FDA 510(k) database K012891
Across registries
- FDA 510(k) K012891 decided 7 Mar 2002 Active
- FDA GUDID UDI-DI 10884521581746 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-0664-05
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
Timeline
- Cleared FDA 510(k) K012891
- Recall initiated FDA recalls Z-0664-05
- Listed FDA GUDID 10884521581746
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nellcor
- Generic name
- Transcutaneous blood gas monitor sensor
- Model / reference
- 10004954
- Primary DI / UDI-DI
- 10884521581746
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Transcutaneous blood gas monitor sensor
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution