# K091650: Axs-590 Series

- Pathway: 510(k) (Traditional)
- Applicant: Swr International, Ltd.
- Decided: Nov 24, 2009 after 168 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
Longest line of descent: 3 generations back to K953815 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020386: Invacare Platinum, Models Irc 5LX and Irc 5LX02, Invacare Corp. (2002) Summary page 1.

## Indications for use
The intended function and use of the SWR International AXS-590Hi and AXS-590i oxygen concentrators is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

Source page: https://510kreport.com/device/K091650
Methodology: https://510kreport.com/methodology