# K032755: Model 509M Pulse Oximeter, Model 509M

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Novametrix, Inc.
- Decided: May 21, 2004 after 259 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993979: MARSPO2, Model 2001, Novametrix Medical Systems, Inc. (2000) Summary page 1.
- K000794: Modification to MARSPO2, Model 2001, Novametrix Medical Systems, Inc. (2000) Summary page 1.

## Recalls of this device
- Sep 2, 2002 · Not classified · Z-1049-04: Audio alarm may fail to sound when SpO2 limits drop below the set limits

## Indications for use
The Model 509M Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well. or poorly perfused in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units.

Source page: https://510kreport.com/device/K032755
Methodology: https://510kreport.com/methodology