# K040484: MAXO2+, Model a and AE

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, Inc.
- Decided: Jun 9, 2004 after 105 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 K935370 (1994). 4 ancestors in all.
9 later devices descend from it; 3 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)
- K023565: Oxicheck, Caradyne, Ltd. (2003) Summary page 1.

## Most influential descendants
- K063488: MAXO2 CU (2007), 7 descendants of its own
- K122290: Envitec Mysign O Oxygen Measuring Device (2013), 3 descendants of its own
- K072845: Precision Flow (2008), 2 descendants of its own
- K183687: LifeWindow LW8 Lite (2019), 1 descendant of its own
- K254078: HVT 2.0 (2026), 0 descendants of its own

## Indications for use
The MAXO 2+ is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture The MAXO 2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.

Source page: https://510kreport.com/device/K040484
Methodology: https://510kreport.com/methodology