# K122560: Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1

- Pathway: 510(k) (Traditional)
- Applicant: Pan-America Hyperbarics, Inc.
- Decided: Mar 26, 2013 after 216 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
Longest line of descent: 2 generations back to K082351 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092264: Atlantis Hyperbaric Chamber Ventilator, Providence Global Medical, Inc. (2009) Summary page 1.

## Indications for use
The Versal Vent Model VI Hyperbaric Chamber Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.

Source page: https://510kreport.com/device/K122560
Methodology: https://510kreport.com/methodology