# K163109: OxyHeal 4000 Multiplace Hyperbaric Chamber Family

- Pathway: 510(k) (Special)
- Applicant: Oxyheal Medical Systems, Inc.
- Decided: Mar 22, 2017 after 135 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 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)
- K152223: Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System, Oxyheal Medical Systems, Inc. (2016) Summary page 4.

## Indications for use
The following indications which are listed on the Undersea & Hyperbaric Medical Society (UHMS) web site: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee. . Air or Gas Embolism . Carbon Monoxide Poisoning . Carbon Monoxide Poisoning Complicated by Cyanide Poisoning . Clostridial Myositis and Myonecrosis (Gas Gangrene) . Crush Injury, Compartment Syndrome and Other Acute Ischemias . Decompression Sickness . Arterial Insufficiencies . Central Retinal Artery Occlusion . Enhancement of Healing in Selected Problem Wounds . Severe Anemia . Intracranial Abscess 9. Necrotizing Soft Tissue Infections 10. Osteomyelitis (Refractory) 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis) 12. Compromised Grafts and Flaps 13. Acute Thermal Burn Injury

Source page: https://510kreport.com/device/K163109
Methodology: https://510kreport.com/methodology