# K974868: Sigma Plus Monoplace Hyperbaric Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Perry Baromedical Corp.
- Decided: Jul 2, 1998 after 185 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 K832127 (1983). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832127: Nautilus Monoplace Hyperbaric Unit, Nautilus Environmedical Systems, Inc. (1983) Summary page 1.

## Most influential descendants
- K990927: Sigma 3400 Monoplace Hyperbaric Chamber (1999), 4 descendants of its own
- 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
- K072427: Sigma Series Hyperbaric Chamber (2008), 0 descendants of its own
- K053498: Hyperox 101 (2006), 0 descendants of its own

## Indications for use
The monoplace hyperbaric chamber is indicated for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: Air or Gas Embolism Carbon Monoxide / Smoke Inhalation Compromised Skin Grafts and Flaps Crush Injuries / Acute Traumatic Ischemias Decompression Sickness Enhanced Healing in Selected Problem Wounds Exceptional Blood Loss (Anemia) Gas Gangrene (Clostridial Myonecrosis) Intracranial Abscess Necrotizing Soft Tissue Infections Radiation Tissue Damage (Osteoradionecrosis) Refractory Osteomyelitis Thermal Burns

Source page: https://510kreport.com/device/K974868
Methodology: https://510kreport.com/methodology