# K013472: Total O2

- Pathway: 510(k) (Traditional)
- Applicant: Chad Therapeutics, Inc.
- Decided: Nov 28, 2001 after 41 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: 1 generation back to K971889 (1997). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K053240: Devilbiss Oxygen Cylinder Filling System, 535 Series (2006), 2 descendants of its own
- K091191: Gas Transfill (2009), 1 descendant of its own
- K141967: Purefill Oxygen Compressor (2014), 0 descendants of its own
- K091028: Omni 5 Total O2 Delivery System (2009), 0 descendants of its own

## Indications for use
The modified Chad Total O,™ Delivery System is intended for use in the same manner as the unmodified device: The Total O,™ Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.

Source page: https://510kreport.com/device/K013472
Methodology: https://510kreport.com/methodology