# K052866: Oxyheal 1000 Monoplace Hyperbaric Chamber

- Pathway: 510(k) (Abbreviated)
- Applicant: Oxyheal Health Group
- Decided: Dec 13, 2005 after 63 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: 3 generations back to K862198 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020974: Bara-Med Acrylic Monoplace Hyperbaric Chamber, Environmental Tectonics Corp. (2002) Summary page 1.
- K011866: Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series, Hyperbaric Technologies, Inc. (2002) Summary page 1.

## Indications for use
1. Air or Gas Embolism 2. Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning 3. Clostridal Myositis and Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome, and other Acute Traumatic Ischemias 5. Decompression Sickness 6. Enhancement of Healing in Selected Problem Wounds 7. Exceptional Blood Loss (Anemia) 8. Intracranial Abscess 9. Necrotizing Soft Tissue Infections 10. Osteomyelitis (Refractory) 11. Delayed Radiation Injury (Sofi Tissue and Bony Necrosis) 12. Skin Grafts & Flaps (Compromised) 13. Therm:! Burns

Source page: https://510kreport.com/device/K052866
Methodology: https://510kreport.com/methodology