# K981938: Tampa Hyperbaric Monoplace Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Tampa Hyperbaric Ent.
- Decided: Jul 6, 1999 after 399 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.
3 later devices descend from it; 1 cites it directly.
0 of 5 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 4.

## 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
- K053498: Hyperox 101 (2006), 0 descendants of its own

## Indications for use
Carbon monoxide poisoning with or without cyanide complications Smoke inhalation Decompression sickness Exceptional blood loss or anemia Clostridial myonecrosis (gangrene) Selected problem chronic wounds Crush injury, compartment syndrome and acute traumatic ischemias Compromised skin grafts Osteomyelitis Thermal burns Osteoradionecrosis (radiation burns) Necrotizing soft tissue infections Air or Gas Embolism

Source page: https://510kreport.com/device/K981938
Methodology: https://510kreport.com/methodology