# K960389: Hyperbaric Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Tampa Hyperbaric Ent.
- Decided: Dec 5, 1996 after 318 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). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 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 3.
- K930748: Sigma MP Multiplace Hyperbaric Chamber, Perry Baromedical Services (1993)

## Most influential descendants
- K011866: Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series (2002), 3 descendants of its own
- K152223: Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System (2016), 1 descendant of its own
- K163109: OxyHeal 4000 Multiplace Hyperbaric Chamber Family (2017), 0 descendants of its own
- K052866: Oxyheal 1000 Monoplace Hyperbaric Chamber (2005), 0 descendants of its own
- K030418: Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System (2004), 0 descendants of its own

## Indications for use
Decompression sickness; Carbon monoxide with or without cyanide poisoning; Smoke inhalation; Exceptional blood loss; Clostridial myonecrosis; Crush injury, compartment syndrome and acute traumatic ischemias; Selected Problem Wounds; Compromised skin grafts; Osteomyelitis; Osteoradionecrosis; Thermal burns; Necrotizing soft tissue infections.

Source page: https://510kreport.com/device/K960389
Methodology: https://510kreport.com/methodology