# K101154: Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L

- Pathway: 510(k) (Traditional)
- Applicant: Airsep Corp.
- Decided: Mar 28, 2011 after 339 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: 8 generations back to K933081 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960309: Airsep Newlife Dual Six Oxygen Concentrator (Modification), Airsep Corp. (1997) Summary page 1.
- K063454: Pogs, Model 33C, On Site Gas Systems, Inc. (2007) Summary page 1.

## Indications for use
The intended use of the Device is to generate and deliver USP 93% oxygen for supplemental oxygen use only or filling cylinders. The device must not be used for or with any life-supporting applications. The Device is intended to be used only by trained personnel in hospitals, health care facilities or remote locations where bottled oxygen is not readily available. The instruction manual of the device recommends an alternate source of supplemental oxygen in the event of a power outage, alarm condition, or mechanical failure.

Source page: https://510kreport.com/device/K101154
Methodology: https://510kreport.com/methodology