# K152223: Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

- Pathway: 510(k) (Traditional)
- Applicant: Oxyheal Medical Systems, Inc.
- Decided: Apr 29, 2016 after 266 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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 4.
- K011866: Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series, Hyperbaric Technologies, Inc. (2002) Summary page 4.

## Most influential descendants
- K163109: OxyHeal 4000 Multiplace Hyperbaric Chamber Family (2017), 0 descendants of its own

## Indications for use
The following indications which are listed on the Undersea and Hyperbaric Medical Society (UHMS) website: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee. 1. Air or Gas Embolism 2. Carbon Monoxide Poisoning a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning 3. Clostridial Myositis and Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Ischemias 5. Decompression Sickness 6. Arterial Insufficiencies a. Central Retinal Artery Occlusion b. Enhancement of Healing in Selected Problem Wounds 7. Severe Anemia 8. 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/K152223
Methodology: https://510kreport.com/methodology