# K162968: Vortran GO2VENT

- Pathway: 510(k) (Traditional)
- Applicant: Vortran Medical Technology 1, Inc.
- Decided: Apr 10, 2017 after 168 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: 2 generations back to K944349 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041473: Var-Plus (Vortran Automatic Resuscitator), Model PCM, Vortran Medical Technology 1, Inc. (2004) Summary page 4.

## Most influential descendants
- K202219: VORTRAN GO2VENT with PEEP Valve (2021), 0 descendants of its own

## Indications for use
This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.

Source page: https://510kreport.com/device/K162968
Methodology: https://510kreport.com/methodology