# K131968: Longfian Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Longfian Scitech Co., Ltd.
- Decided: Sep 5, 2014 after 434 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: 1 generation back to K083559 (2009). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083559: Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (2009) Summary page 4.

## Most influential descendants
- K213210: Oxygen Concentrator, Model JAY-5AW (2022), 0 descendants of its own
- K191875: Owgels Oxygen Concentrator (2020), 0 descendants of its own

## Indications for use
The Longfian Oxygen Concentrator, Model Jay-5 is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model Jay-5 can be used in a home, institution, vehicle, and various mobile environments. The Longfian Oxygen Concentrator, Model Jay-5 does not nor is it intended to sustain or support life.

Source page: https://510kreport.com/device/K131968
Methodology: https://510kreport.com/methodology