# K252399: Portable Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Honsun (Nantong) Co., Ltd.
- Decided: Jun 17, 2026 after 321 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 6.

## Indications for use
The Portable Oxygen Concentrator (Model: Ares-6A, Ares-4A) provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Source page: https://510kreport.com/device/K252399
Methodology: https://510kreport.com/methodology