# K020324: Lifestyle Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Airsep Corp.
- Decided: Mar 13, 2002 after 41 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 5 cite it directly.
0 of 28 devices 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.

## Most influential descendants
- K073242: Portable Oxygen Concentrator, Model RS-00400 (2008), 10 descendants of its own
- K162433: GCE Zen-O Portable Oxygen Concentrator (2017), 8 descendants of its own
- K032818: Inogen One Oxygen Concentrator (2004), 8 descendants of its own
- K210371: Portable Oxygen Concentrator, model: P2-E6 (2022), 6 descendants of its own
- K230702: Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) (2023), 3 descendants of its own

## Recalls of this device
- Oct 4, 2024 · Class II · Z-0479-2025: Potential failure of affected units to recharge the battery of the oxygen concentrators.
- Oct 4, 2024 · Class II · Z-0478-2025: Potential failure of affected units to recharge the battery of the oxygen concentrators.
- Jan 14, 2013 · Class II · Z-0768-2013: Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.

## Indications for use
The portable AirSep LifeStyle Oxygen Concentrator is intended to provide supplemental, high-purity oxygen in a home, institutional, or travel environment.

Source page: https://510kreport.com/device/K020324
Methodology: https://510kreport.com/methodology