# K012677: Reprocessed Pulse Oximeter Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Mar 28, 2003 after 591 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: 1 generation back to K863784 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 5.

## Most influential descendants
- K041127: Modification to: Reprocessed Oximax Pulse Oximeter Sensors (2004), 0 descendants of its own

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

Source page: https://510kreport.com/device/K012677
Methodology: https://510kreport.com/methodology