# K242736: Portable Oxygen Concentrator (Spirit-3)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Jun 5, 2025 after 267 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: 5 generations back to K020324 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230702: Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3), Qingdao Kingon Medical Science and Technology Co., Ltd. (2023) Summary page 6.

## Indications for use
The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.

Source page: https://510kreport.com/device/K242736
Methodology: https://510kreport.com/methodology