# K091028: Omni 5 Total O2 Delivery System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Jul 23, 2009 after 104 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: 2 generations back to K971889 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013472: Total O2, Chad Therapeutics, Inc. (2001) Summary page 1.
- K971889: Chad Total O2 Delivery System, Chad Therapeutics, Inc. (1997) Summary page 1.

## Indications for use
The Omni-5 Total 02 Delivery System is intended to supply low-pressure supplemental oxygen for the treatment of Respiratory Diseases in children through adults in the home, health care facility or hospital and to supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use.

Source page: https://510kreport.com/device/K091028
Methodology: https://510kreport.com/methodology