# K053498: Hyperox 101

- Pathway: 510(k) (Traditional)
- Applicant: Wjo, Inc.
- Decided: Mar 15, 2006 after 89 days
- Product code: CBF (Chamber, Hyperbaric)
- Device class: 2
- Regulation: 21 CFR 868.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K832127 (1983). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031649: SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities, Fink Engineering Pty, Ltd. (2003) Summary page 3.
- K021693: Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1, Pan-America Hyperbarics, Inc. (2002) Summary page 1.
- K930748: Sigma MP Multiplace Hyperbaric Chamber, Perry Baromedical Services (1993) Summary page 1.

## Indications for use
Air or gas embolism Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning Clostridial myositis and myonecrosis Crush injury, compartment syndrome, and other acute traumatic ischememias iDecompression sickness Enhanced of selected problem wounds Exceptional blood loss anemia Necrotizing soft tissue infections Osteomyelitis (refractory) Delayed radiation injury (soft tissue and bony necrosis) Skin grafts and flaps (compromised) Thermal bums Intercranial abscess

Source page: https://510kreport.com/device/K053498
Methodology: https://510kreport.com/methodology