# K993010: Bara-Med, Acrylic Monoplace Hyperbaric Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Environmental Tectonics Corp.
- Decided: May 30, 2000 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: 1 generation back to K934164 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 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.
- (no number) Dixie Manufacturing Co.’s Dixie 800-45: named in the summary without a submission number
- (no number) Perry Baromedical’s Sigma I: named in the summary without a submission number
- (no number) Sechrist Industry’s Sechrist 2500: named in the summary without a submission number

## Most influential descendants
- K021693: Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 (2002), 2 descendants of its own
- K081506: Hyperbaric America, LLC,  Presidential Monoplace Hyperbaric Chamber Systems (2008), 0 descendants of its own
- K053498: Hyperox 101 (2006), 0 descendants of its own

## Indications for use
All of the contemporary substantially equivalent systems listed in Attachment 12 are used for the same indications as listed in the Hyperbaric Oxygen Therapy: Committee Report, Undersea and Hyperbaric Medical Society, Inc., Revised 1999. 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/K993010
Methodology: https://510kreport.com/methodology