# K032949: Spot Check Pulse Oximeter,512/513

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Novametrix, Inc.
- Decided: Aug 23, 2004 after 336 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924626 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924626: Novametrix Model 510, Novametrix Medical Systems, Inc. (1993) Summary page 1.

## Recalls of this device
- Sep 27, 2010 · Not classified · Z-0550-2011: Unit may overestimate Sp02 levels in a high humidity environment.
- Sep 27, 2010 · Not classified · Z-0551-2011: Unit may overestimate Sp02 levels in a high humidity environment.

## Indications for use
The Model 512 Handheld Pulse Oximeter is intended to provide non-invasive spot checking of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport. The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport. The monitor and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgment of a licensed medical practitioner

Source page: https://510kreport.com/device/K032949
Methodology: https://510kreport.com/methodology