# K983648: Sigma Plus/ II Multiplace Hyperbaric System

- Pathway: 510(k) (Traditional)
- Applicant: Perry Baromedical Services
- Decided: Feb 24, 1999 after 131 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 K862198 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862198: Sigma II - Dual Place Hyperbaric Chamber, Perry Baromedical Services (1986) Summary page 1.

## Most influential descendants
- K021690: Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1 (2002), 0 descendants of its own

## Indications for use
The SIGMA Plus / II Multiplace hyperbaric System 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/K983648
Methodology: https://510kreport.com/methodology