# K120785: Omni 3 Oxygen System

- Pathway: 510(k) (Special)
- Applicant: Caire, Inc.
- Decided: Oct 25, 2012 after 224 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: 5 generations back to K933081 (1994). 7 ancestors in all.
9 later devices descend from it; 2 cite it directly.
3 of 17 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) Summary page 2.
- K083163: Omni 2 Oxygen System, Sequal Technologies, Inc. (2009) Summary page 1.

## Most influential descendants
- K162877: VOCSN Unified Respiratory System (2017), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K242718: Portable Oxygen Concentrator (P2-TOC) (2025), 1 descendant of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own

## Indications for use
The eQuinox Oxygen System is intended for the administration of supplemental oxygen.

Source page: https://510kreport.com/device/K120785
Methodology: https://510kreport.com/methodology