# K063488: MAXO2 CU

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, Inc.
- Decided: Feb 22, 2007 after 97 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: 4 generations back to K935370 (1994). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040484: MAXO2+, Model a and AE, Maxtec, Inc. (2004) Summary page 1.
- K973282: Handi Oxygen Analyzer, Ceramatec, Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K010328: Multiple (Izon Dna Blood Collection Kit), Izon Business Products, Inc. (2001). Our reading of the summary gave K010328, FDA’s number for Multiple (Izon Dna Blood Collection Kit) (Izon Business Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sensidyne”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own

## Indications for use
The MaxO 2 CU is a continuous use monitor of oxygen concentration in a patient breathing environment. It may be provided with an oxygen concentration dilution method which could be of a flowmeter, manifold or venturi design, which can deliver set or adjustable FiO 2 oxygen concentrations and flow rates to the patient. It is not intended for use with life supporting systems.

Source page: https://510kreport.com/device/K063488
Methodology: https://510kreport.com/methodology