# K013931: Omni Oxygen System, Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Sequal Technologies, Inc.
- Decided: Mar 27, 2002 after 119 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: 3 generations back to K933081 (1994). 5 ancestors in all.
38 later devices descend from it; 10 cite it directly.
4 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003472: Integra Oxygen Concentrators Model 6400-OM, Sequal Technologies, Inc. (2001) Summary page 1.
- K963042: Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853, Sim Italia S.R.L. (1996) Summary page 1.

## Most influential descendants
- K083163: Omni 2 Oxygen System (2009), 18 descendants of its own
- K120785: Omni 3 Oxygen System (2012), 9 descendants of its own
- K093261: MOVES (2010), 7 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

## Recalls of this device
- Oct 1, 2009 · Not classified · Z-0567-2010: Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate sup

## Indications for use
The Model 1000 Omni Oxygen System is indicated 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/K013931
Methodology: https://510kreport.com/methodology