# K221734: Maxtec MaxO2 ME+p

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, LLC
- Decided: Apr 1, 2023 after 290 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: 3 generations back to K911344 (1991). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153659: MaxO2ME, Maxtec, LLC (2016) Summary page 4.
- K992101: Criterion 40 or PM 40, Caradyne, Ltd. (2000) Summary page 4.

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

## Indications for use
The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

Source page: https://510kreport.com/device/K221734
Methodology: https://510kreport.com/methodology