# K072427: Sigma Series Hyperbaric Chamber

- Pathway: 510(k) (Abbreviated)
- Applicant: Perry Baromedical Corp.
- Decided: Jun 11, 2008 after 287 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: 3 generations back to K832127 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990927: Sigma 3400 Monoplace Hyperbaric Chamber, Perry Baromedical Corp. (1999) Summary page 1.
- K052713: Model 3300E/ER Monoplace Hyperbaric Oxygen Chamber, Sechrist Industries, Inc. (2005) Summary page 1.
- K020974: Bara-Med Acrylic Monoplace Hyperbaric Chamber, Environmental Tectonics Corp. (2002) Summary page 1.

## Indications for use
The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: 1. Air or Gas Embolism 2. Carbon Monoxide / Smoke Inhalation 3. Compromised Skin Grafts and Flaps 4. Crush Injuries / Acute Traumatic Ischemia 5. Decompression Sickness 6. Enhanced Healing in Selected Problem Wounds 7. Exceptional Blood Loss (Anemia) 8. Gas Gangrene (Clostridia Myonecrosis) 9. Intracranial Abscess 10. Necrotizing Soft Tissue Infections 11. Radiation Tissue Damage (Osteoradionecrosis) 12. Refractory Osteomyelitis 13. Thermal Burns

Source page: https://510kreport.com/device/K072427
Methodology: https://510kreport.com/methodology