# K051322: Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical International, Ltd.
- Decided: Aug 5, 2005 after 77 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932170 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932170: Flynnr Genesis II a/C, a/O and Idlh, O-Two Systems Intl., Inc. (1993) Summary page 1.

## Most influential descendants
- K193191: MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (2020), 0 descendants of its own
- K071527: Pneupac VR1 Air Mix (2007), 0 descendants of its own

## Recalls of this device
- May 16, 2007 · Not classified · Z-0991-2007: Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilato

## Indications for use
The Pneupac VR1 range are hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. They are designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions: * Pneupac VR1 Standard - Ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with either respiratory distress/ insufficency or no respiratory function. * Pneupac VR1 Responder - Basic ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with no respiratory function.

Source page: https://510kreport.com/device/K051322
Methodology: https://510kreport.com/methodology