# K132759: Ventrain

- Pathway: 510(k) (Traditional)
- Applicant: Dolphys Medical B.V.
- Decided: Mar 26, 2014 after 203 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K112783 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112783: Manujet Iii, VBM Medizintechnik GmbH (2011) Summary page 2.

## Indications for use
For emergency ventilation via a small lumen transtracheal catheter, in case conventional ventilation by mask and/or a large-bore endotracheal tube cannot be performed. Ventilation is accomplished by manual, intermittent ventilation with oxygen through the catheter for subsequent lung inflation and deflation.

Source page: https://510kreport.com/device/K132759
Methodology: https://510kreport.com/methodology