# K051271: Oximax Neomax Adhesive Forehead Reflectance Oximetry Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Jan 10, 2006 after 238 days
- Product code: DQA (Oximeter)
- 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: 6 generations back to K962603 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002)
- K021089: Oximax Max-Fast Adhesive Forehead Sensor, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## Indications for use
The Nellcor® OxiMax*' NeoMAX adhesive forehead reflectance sensor is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (< 40 kg).

Source page: https://510kreport.com/device/K051271
Methodology: https://510kreport.com/methodology