# K052186: Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-P

- Pathway: 510(k) (Special)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Nov 10, 2005 after 91 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.
3 later devices descend from it; 2 cite it directly.
0 of 14 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) Summary page 1.
- K021089: Oximax Max-Fast Adhesive Forehead Sensor, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## Most influential descendants
- K181738: Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors (2019), 1 descendant of its own
- K201699: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (2020), 0 descendants of its own
- K103584: Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda  Compatible Disposable and Reusable SPO2 Sensors (2011), 0 descendants of its own

## Indications for use
The Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients in the sizes indicated in the respective sensor directions for use.

Source page: https://510kreport.com/device/K052186
Methodology: https://510kreport.com/methodology