# K003472: Integra Oxygen Concentrators Model 6400-OM

- Pathway: 510(k) (Traditional)
- Applicant: Sequal Technologies, Inc.
- Decided: Jun 4, 2001 after 208 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
No predicates in its family tree.
46 later devices descend from it; 4 cite it directly.
4 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013931: Omni Oxygen System, Model 1000 (2002), 38 descendants of its own
- 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

Source page: https://510kreport.com/device/K003472
Methodology: https://510kreport.com/methodology