# K033405: Longfei Lfy-I-5 Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Longfei Industrial Co., Ltd.
- Decided: Oct 18, 2005 after 725 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: 3 generations back to K953815 (1995). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020386: Invacare Platinum, Models Irc 5LX and Irc 5LX02, Invacare Corp. (2002)

## Most influential descendants
- K090007: Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 (2009), 4 descendants of its own
- K230969: Oxygen Concentrator (2023), 3 descendants of its own
- 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

## Indications for use
The LFY-l-5 Oxygen Concentrators are indicated fro the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K033405
Methodology: https://510kreport.com/methodology