# K162433: GCE Zen-O Portable Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Oxus, Inc.
- Decided: May 24, 2017 after 266 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020324 (2002). 2 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073242: Portable Oxygen Concentrator, Model RS-00400, Delphi Medical Systems (2008) Summary page 4.

## Most influential descendants
- 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
- K223379: Portable Oxygen Concentrator (Model: P2-E7, P2-E) (2023), 2 descendants of its own
- K242718: Portable Oxygen Concentrator (P2-TOC) (2025), 1 descendant of its own
- K252268: V series portable oxygen concentrator (V5, V5C, V6, V6C) (2025), 0 descendants of its own

## Recalls of this device
- May 8, 2025 · Class II · Z-1980-2025: Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

## Indications for use
The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.

Source page: https://510kreport.com/device/K162433
Methodology: https://510kreport.com/methodology