# K251764: Oxygen Concentrator-P2-O5E

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Kingon Medical Science and Technology Co., Ltd.
- Decided: Dec 22, 2025 after 196 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150930: Deployable Oxygen Generation System-Smaill (DOGS-S), Airsep Corporation (2015) Summary page 5.

## Indications for use
The oxygen concentrator P2-05E is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.

Source page: https://510kreport.com/device/K251764
Methodology: https://510kreport.com/methodology