# K003455: Modification to Chad Therapeutics Oxymatic Model 401

- Pathway: 510(k) (Special)
- Applicant: Chad Therapeutics, Inc.
- Decided: Dec 6, 2000 after 29 days
- Product code: NFB (Conserver, Oxygen)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 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
- K042142: Chad Therapeutics Lotus, Models OM-700 and OM-700S (2004), 3 descendants of its own
- K103392: Chad Therapeutic Evolution Electronic Oxygen Conserver (2010), 2 descendants of its own
- K033364: Chad Therapeutics Sage (2004), 2 descendants of its own
- K113111: Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion (2011), 1 descendant of its own
- K220591: Proxima (2022), 0 descendants of its own

## Recalls of this device
- Mar 25, 2005 · Not classified · Z-1068-05: "Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.

Source page: https://510kreport.com/device/K003455
Methodology: https://510kreport.com/methodology