# K260171: Portable Oxygen Concentrator (PO1 5B, PO1 6B)

- Pathway: 510(k) (Traditional)
- Applicant: BMC Medical Co., Ltd.
- Decided: Aug 14, 2026 after 205 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 device is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. It is intended for both home healthcare environment and the professional healthcare facility environment. It is intended for adults only, prescription required.

Source page: https://510kreport.com/device/K260171
Methodology: https://510kreport.com/methodology