# K071527: Pneupac VR1 Air Mix

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical International, Ltd.
- Decided: Oct 4, 2007 after 122 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 K932170 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051322: Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus, Smiths Medical International, Ltd. (2005) Summary page 2.
- K010793: Oxylog 1000, Model 2M86840, Drager Medizintechnik GmbH (2001)

## Indications for use
The Pneupac VR1 Airmix is a hand-held, portable, time cycled, gas powered, flow generator ventilatory resuscitator that is suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. It is designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions: Pneupac VR1 Airmix - Ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with either respiratory distress/ insufficiency or no respiratory function and including a control for providing oxygen concentrations of either 100% or 50% nominal.

Source page: https://510kreport.com/device/K071527
Methodology: https://510kreport.com/methodology