# K153659: MaxO2ME

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, LLC
- Decided: Jun 10, 2016 after 172 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911344 (1991). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063096: Precision Oxygen Monitor, Precision Medical, Inc. (2007) Summary page 4.

## Most influential descendants
- K221734: Maxtec MaxO2 ME+p (2023), 2 descendants of its own
- K251245: OxyMinder Pro (10310) (2025), 0 descendants of its own
- K231895: Maxtec MaxBlend2+p (2023), 0 descendants of its own
- K213948: OxyMinder (2022), 0 descendants of its own

## Indications for use
The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device.

Source page: https://510kreport.com/device/K153659
Methodology: https://510kreport.com/methodology