# K092368: Reprocessed Pulse Oximeter Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Nov 3, 2009 after 90 days
- Product code: NLF (Oximeter, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K941811 (1994). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041815: LNCS Oximetry Sensors, Masimo Corp. (2004) Summary page 1.
- K051212: Modification to LNCS Oximetry Sensors, Masimo Corporation (2005) Summary page 1.
- K060143: LNCS and SPO2.Com Sensors, Masimo Corporation (2006) Summary page 1.
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2003) Summary page 1.

## Indications for use
The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO) and pulse rate monitoring.

Source page: https://510kreport.com/device/K092368
Methodology: https://510kreport.com/methodology