# K091541: Mesa Oxygen Concentrator, Model 2-6000 Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Sequal Technologies Co., Ltd.
- Decided: Dec 31, 2009 after 219 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: 1 generation back to K003472 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003472: Integra Oxygen Concentrators Model 6400-OM, Sequal Technologies, Inc. (2001) Summary page 1.
- K071397: Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 Series, Sunrise Medical (2007) Summary page 1.

## Indications for use
The MESA Oxygen Concentrator (Model No.: 2-6000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K091541
Methodology: https://510kreport.com/methodology