# K990927: Sigma 3400 Monoplace Hyperbaric Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Perry Baromedical Corp.
- Decided: Nov 12, 1999 after 238 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: 2 generations back to K832127 (1983). 2 ancestors in all.
4 later devices descend from it; 3 cite 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.
- K974868: Sigma Plus Monoplace Hyperbaric Chamber, Perry Baromedical Corp. (1998). Our OCR of the scanned summary read K974863, FDA’s number for Imix Digital Thorax System (Advanced Instrument Development, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Perry Baromedical Corporation SIGMA Plus Monoplace Hyperbaric Chamber”.

## 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
- K072427: Sigma Series Hyperbaric Chamber (2008), 0 descendants of its own
- K053498: Hyperox 101 (2006), 0 descendants of its own

## Indications for use
The SIGMA 3400 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/K990927
Methodology: https://510kreport.com/methodology