# K862198: Sigma II - Dual Place Hyperbaric Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Perry Baromedical Services
- Decided: Nov 12, 1986 after 156 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.
12 later devices descend from it; 4 cite it directly.
0 of 13 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
- K960389: Hyperbaric Chamber (1996), 5 descendants of its own
- K011866: Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series (2002), 3 descendants of its own
- K981938: Tampa Hyperbaric Monoplace Chamber (1999), 3 descendants of its own
- K021693: Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 (2002), 2 descendants of its own
- K152223: Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System (2016), 1 descendant of its own

Source page: https://510kreport.com/device/K862198
Methodology: https://510kreport.com/methodology