# K023565: Oxicheck

- Pathway: 510(k) (Abbreviated)
- Applicant: Caradyne, Ltd.
- Decided: Mar 28, 2003 after 156 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 K935370 (1994). 3 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K973282: Handi Oxygen Analyzer, Ceramatec, Inc. (1998) Summary page 1.
- K000959: Criterion 60 or PM 60, Caradyne, Ltd. (2000)

## Most influential descendants
- K040484: MAXO2+, Model a and AE (2004), 9 descendants of its own
- 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

## Indications for use
The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture. The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient. The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care. The OxiCheck is not intended for use in a MRI environment.

Source page: https://510kreport.com/device/K023565
Methodology: https://510kreport.com/methodology