# K081506: Hyperbaric America, LLC,  Presidential Monoplace Hyperbaric Chamber Systems

- Pathway: 510(k) (Abbreviated)
- Applicant: Hyperbaric America, LLC
- Decided: Jul 25, 2008 after 57 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934164: Model 2500E/2500ER Hyperbaric Chamber, Sechrist Industries, Inc. (1995) Summary page 1.
- K950386: Model 3200P/3200PR Hyperbaric Chamber, Sechrist Industries, Inc. (1995) Summary page 1.
- K832127: Nautilus Monoplace Hyperbaric Unit, Nautilus Environmedical Systems, Inc. (1983) Summary page 1.
- K990927: Sigma 3400 Monoplace Hyperbaric Chamber, Perry Baromedical Corp. (1999) Summary page 1.
- K993010: Bara-Med, Acrylic Monoplace Hyperbaric Chamber, Environmental Tectonics Corp. (2000) Summary page 1.
- K021693: Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1, Pan-America Hyperbarics, Inc. (2002) Summary page 1.
- K002795: Model Hybrid 3200 Monoplace, Hyperbaric Therapy Systems, Hypertec, Inc. (2000) Summary page 1.

## Indications for use
It is the expressed, intended use of the Hyperbaric America, LLC, Presidential Hyperbaric Chamber Systems 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 its procurement and routine use. The conditions listed as appropriate for the use of HBO by the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003) are 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 healing 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 burns 13. Intracranial abscess

Source page: https://510kreport.com/device/K081506
Methodology: https://510kreport.com/methodology