Nonin 8100SM
Nonin 8100SM is a Class II device made by Nonin Medical, Inc., cleared under FDA 510(k) K132402 on 21 Feb 2014 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 00849686073386), 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 | Number00849686073386 | Date24 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132402 | Date21 Feb 2014 | StatusActive |
Official records
- AccessGUDID record 00849686073386
- FDA 510(k) database K132402
Across registries
- FDA 510(k) K132402 decided 21 Feb 2014 Active
- FDA GUDID UDI-DI 00849686073386 listed 24 Aug 2016 Listed
Recalls
-
- Terminated Z-0901-2015
Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.
Timeline
- Cleared FDA 510(k) K132402
- Recall initiated FDA recalls Z-0901-2015
- Listed FDA GUDID 00849686073386
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nonin
- Generic name
- Pulse oximeter probe, reusable
- Model / reference
- 8100SM
- Primary DI / UDI-DI
- 00849686073386
- 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
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Pulse oximeter probe, reusable.