# K191875: Owgels Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Life Light Electronic Technology Co., Ltd.
- Decided: Jul 20, 2020 after 374 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: 2 generations back to K083559 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131968: Longfian Oxygen Concentrator, Longfian Scitech Co., Ltd. (2014) Summary page 4.

## Indications for use
The Owgels Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator does not nor is it intended to sustain or support life. The device is intended for use in adults.

Source page: https://510kreport.com/device/K191875
Methodology: https://510kreport.com/methodology