# K250625: Portable oxygen concentrator  (W-R1(MAX)); Portable oxygen concentrator  (W-R1); Portable oxygen concentrator  (W-R2); Portable oxygen concentrator  (W-R2(Lite))

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Yinuoji Medical Technology Co., Ltd.
- Decided: Aug 27, 2025 after 177 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 K203086 (2021). 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)
- K230052: Inogen Rove 6, Inogen, Inc. (2023) Summary page 5.

## Indications for use
The Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients requiring respiratory therapy on a prescriptive basis. It may be used at home, in institution, vehicle, train, airplane, boats and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting. Users should follow their doctor's advice on setting the oxygen flow rate and should not adjust the flow rate without consulting a healthcare professional. Note: Patients should regularly consult with their physician to evaluate the need for adjustments in their oxygen therapy settings.

Source page: https://510kreport.com/device/K250625
Methodology: https://510kreport.com/methodology