# K223740: Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.
- Decided: Oct 5, 2023 after 295 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in home, institution environments. The device is not intended to sustain or support life. The device is intended for use in adults.

Source page: https://510kreport.com/device/K223740
Methodology: https://510kreport.com/methodology