# K832127: Nautilus Monoplace Hyperbaric Unit

- Pathway: 510(k) (Traditional)
- Applicant: Nautilus Environmedical Systems, Inc.
- Decided: Aug 12, 1983 after 42 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 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
- K974868: Sigma Plus Monoplace Hyperbaric Chamber (1998), 5 descendants of its own
- K990927: Sigma 3400 Monoplace Hyperbaric Chamber (1999), 4 descendants of its own
- 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
- K072427: Sigma Series Hyperbaric Chamber (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K832127
Methodology: https://510kreport.com/methodology