# K002795: Model Hybrid 3200 Monoplace, Hyperbaric Therapy Systems

- Pathway: 510(k) (Traditional)
- Applicant: Hypertec, Inc.
- Decided: Dec 6, 2000 after 90 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K002795
Methodology: https://510kreport.com/methodology