# K252268: V series portable oxygen concentrator (V5, V5C, V6, V6C)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Harveymed Technology Co., Ltd.
- Decided: Dec 16, 2025 after 148 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: 7 generations back to K933081 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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.
- K242718: Portable Oxygen Concentrator (P2-TOC), Qingdao Kingon Medical Science and Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
The V series Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis in a home, institutional, or travel environment. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K252268
Methodology: https://510kreport.com/methodology