# K243833: Portable oxygen concentrator (JAY-1000P)

- Pathway: 510(k) (Traditional)
- Applicant: Longfian Scitech Co., Ltd.
- Decided: Sep 29, 2025 after 290 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: 4 generations back to K020324 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210371: Portable Oxygen Concentrator, model: P2-E6, Qingdao Kingon Medical Science and Technology Co., Ltd. (2022) Summary page 6.

## Indications for use
The Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment (not include emergency medical services environment). The oxygen concentrator for adult use, providing pulsed oxygen flow.

Source page: https://510kreport.com/device/K243833
Methodology: https://510kreport.com/methodology