# K180837: CONTEC Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Jan 10, 2019 after 286 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 K020324 (2002). 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)
- K162433: GCE Zen-O Portable Oxygen Concentrator, Oxus, Inc. (2017) Summary page 5.

## Indications for use
CONTEC™ Oxygen Concentrator, OC3D, is intended to provide supplemental oxygen in a home, institutional environment. The device is only used for adult and prescription use only.

Source page: https://510kreport.com/device/K180837
Methodology: https://510kreport.com/methodology