# K021089: Oximax Max-Fast Adhesive Forehead Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Jun 19, 2002 after 76 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: 5 generations back to K962603 (1997). 9 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 23 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)

## Most influential descendants
- K122996: Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085 (2013), 3 descendants of its own
- K052186: Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-P (2005), 3 descendants of its own
- K143216: Assurance Alar / Nasal SpO2 Sensor (2015), 2 descendants of its own
- K181738: Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors (2019), 1 descendant of its own
- K171423: Nasal Alar SpO2 Sensor (2017), 1 descendant of its own

## Indications for use
The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (2 10 kg) patients.

Source page: https://510kreport.com/device/K021089
Methodology: https://510kreport.com/methodology