# K083163: Omni 2 Oxygen System

- Pathway: 510(k) (Traditional)
- Applicant: Sequal Technologies, Inc.
- Decided: Oct 20, 2009 after 358 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: 4 generations back to K933081 (1994). 6 ancestors in all.
18 later devices descend from it; 3 cite it directly.
3 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013931: Omni Oxygen System, Model 1000, Sequal Technologies, Inc. (2002)

## Most influential descendants
- K120785: Omni 3 Oxygen System (2012), 9 descendants of its own
- K162877: VOCSN Unified Respiratory System (2017), 6 descendants of its own
- K150930: Deployable Oxygen Generation System-Smaill (DOGS-S) (2015), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K222920: Oxygen concentrator (2023), 3 descendants of its own

## Recalls of this device
- Sep 16, 2019 · Class II · Z-0248-2020: There is an electronics control issue that causes the unit to not power on with battery power only.

## Indications for use
The OMNI 2 Oxygen System is intended for 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/K083163
Methodology: https://510kreport.com/methodology