# K213825: Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Apr 28, 2023 after 506 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: 2 generations back to K972614 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061261: L4 Oxygen Concentrator, Respironics, Inc. (2006) Summary page 5.

## Indications for use
This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.

Source page: https://510kreport.com/device/K213825
Methodology: https://510kreport.com/methodology