# K041127: Modification to: Reprocessed Oximax Pulse Oximeter Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Sep 23, 2004 after 146 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: 2 generations back to K863784 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012677: Reprocessed Pulse Oximeter Sensors, Sterilmed, Inc. (2003) Summary page 1.

## Indications for use
Reprocessed Pulse Oximeter Sensors are used when continuous external monitoring of arterial oxygen saturation and pulse rate is required

Source page: https://510kreport.com/device/K041127
Methodology: https://510kreport.com/methodology