Nellcor I20
by Covidien LP
Nellcor I20 is a Class II device made by Covidien LP, cleared under FDA 510(k) K993637 on 24 Nov 1999 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 30884522000905), 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 | Number30884522000905 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993637 | Date24 Nov 1999 | StatusActive |
Official records
- AccessGUDID record 30884522000905
- FDA 510(k) database K993637
Across registries
- FDA 510(k) K993637 decided 24 Nov 1999 Active
- FDA GUDID UDI-DI 30884522000905 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-0665-05
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
Timeline
- Cleared FDA 510(k) K993637
- Recall initiated FDA recalls Z-0665-05
- Listed FDA GUDID 30884522000905
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nellcor
- Generic name
- Pulse oximeter probe, single-use
- Model / reference
- I20
- Primary DI / UDI-DI
- 30884522000905
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Pulse oximeter probe, single-use
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution