# K082351: Neptune Hyperbaric Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Level-5, Inc.
- Decided: Jan 2, 2009 after 140 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K760852: Sechrist Industries, Inc.'s Hyperbaric Ventilator Model 500A. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K092264: Atlantis Hyperbaric Chamber Ventilator (2009), 1 descendant of its own
- K122560: Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1 (2013), 0 descendants of its own

## Indications for use
The Neptune Hyperbaric Ventilator is indicated for use with patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric therapy.

Source page: https://510kreport.com/device/K082351
Methodology: https://510kreport.com/methodology