# K121167: Caire Companion 5 Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Caire, Inc.
- Decided: May 2, 2012 after 15 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CAIRE Companion 5 Oxygen Concentrator is intended for the administration of supplemental oxygen up to 5 liters/minute. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K121167
Methodology: https://510kreport.com/methodology