# K082455: Rectangular Multiplace Hyperbaric Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Gulf Coast Hyperbarics, Inc.
- Decided: May 22, 2009 after 269 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: 2 generations back to K930748 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 2.
- K930748: Sigma MP Multiplace Hyperbaric Chamber, Perry Baromedical Services (1993) Summary page 2.
- K950957: Multiplace Hyperbaric Treatment Chamber System, Gulf Coast Hyperbarics, Inc. (1995) Summary page 2.

## Indications for use
It is the expressed, intended use of the Gulf Coast Hyperbaric rectangular hyperbaric chamber to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in their procurement and routine use. The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically, the UHMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been scientifically validated and verified through extensive data collection. It should be noted that the list is dynamic. Based on the strength of the scientific data, disorders are both added and removed from the list, depending on the outcomes of scientific pursuit. The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) is as follows: 1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning 3. Clostridial myositis and myonecrosis 4. Crush injury, compartment syndrome, and other acute traumatic ischemias 5. Decompression sickness 6. Enhanced of selected problem wounds 7. Exceptional blood loss anemia 8. Necrotizing soft tissue infections 9. Osteomyelitis (refractory) 10. Delayed radiation injury (soft tissue and bony necrosis) 11. Skin grafts and flaps (compromised) 12. Thermal bums 13. Intracranial abscess

Source page: https://510kreport.com/device/K082455
Methodology: https://510kreport.com/methodology