# K040145: Ata HCM Monoplace Hyperbaric System

- Pathway: 510(k) (Traditional)
- Applicant: Ata Hyperbaric Chamber Manufacturing
- Decided: May 4, 2005 after 468 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The conditions listed as appropriate for the use of the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows: Air or Gas Embolism Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning Clostridial Myositis and Myonecrosis (Gas Gangrene) Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias Decompression Sickness Enhancement of Healing in Selected Problem Wounds Exceptional Blood Loss (Anemia) Intracranial Abscess Necrotizing Soft Tissue Infections Osteomyelitis (Refractory) Delayed Radiation Injury (Soft Tissue and Bony Necrosis) Skin Grafts and Flaps (Compromised) Thermal Burns

Source page: https://510kreport.com/device/K040145
Methodology: https://510kreport.com/methodology