# K100920: Mesa II Oxygen Concentrator Model: T2000 Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Sequal Technologies Co., Ltd.
- Decided: Nov 29, 2010 after 241 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: 6 generations back to K933081 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042262: Integra Oxygen Concentrator, Model 6323A-OM-10, Sequal Technologies, Inc. (2004) Summary page 1.
- K043006: Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605, Respironics, Inc. (2005) Summary page 1.

## Indications for use
The MESA 11 Oxygen Concentrator (Model No.: T2000 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/K100920
Methodology: https://510kreport.com/methodology