# K213933: Percent Oxygen Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Careox, LLC
- Decided: Aug 19, 2022 after 246 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: 1 generation back to K952736 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952736: Percent Oxygen Sensor, Analytical Industries, Inc. (1995) Summary page 4.

## Indications for use
Percent Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

Source page: https://510kreport.com/device/K213933
Methodology: https://510kreport.com/methodology