# K202219: VORTRAN GO2VENT with PEEP Valve

- Pathway: 510(k) (Traditional)
- Applicant: Vortran Medical Technology 1, Inc.
- Decided: Feb 11, 2021 after 189 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: 3 generations back to K944349 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162968: Vortran GO2VENT, Vortran Medical Technology 1, Inc. (2017) Summary page 4.

## Indications for use
The VORTRAN G02VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.

Source page: https://510kreport.com/device/K202219
Methodology: https://510kreport.com/methodology