# K230969: Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
- Decided: Nov 9, 2023 after 218 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953815 (1995). 10 ancestors in all.
3 later devices descend from it; 3 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090007: Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000, Danyang Jumao Healthcare Equipment Co., Ltd. (2009) Summary page 5.

## Most influential descendants
- K252965: Oxygen Concentrator (OX-5A, OX-5C) (2026), 0 descendants of its own
- K253549: DeVilbiss 5 Liter Oxygen Concentrator (555) (2026), 0 descendants of its own
- K250805: DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (2025), 0 descendants of its own

## Recalls of this device
- Dec 9, 2024 · Class I · Z-0795-2025: Oxygen concentrator may melt or catch on fire during use.

## Indications for use
The JUMAO Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

Source page: https://510kreport.com/device/K230969
Methodology: https://510kreport.com/methodology