510(k) · Cleared
Recalled · 2007Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical International, Ltd. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Aug 5, 2005 as substantially equivalent to K932170 (O-Two Systems Intl., Inc., 1993) after a 77-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 5, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- BTL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932170 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK932170 Flynnr Genesis II a/C, a/O and IdlhO-Two Systems Intl., Inc. · 1993
- This deviceK051322 Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model…Smiths Medical International, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK193191 MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KG · 2020
- Descendant · cites it directly · 0 of its ownK071527 Pneupac VR1 Air MixSmiths Medical International, Ltd. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932170 | Flynnr Genesis II a/C, a/O and Idlh | O-Two Systems Intl., Inc. | 1993 | — |
| 0 (this device) | K051322 | Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus | Smiths Medical International, Ltd. | 2005 | — |
| +1 | K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020 | — |
| +1 | K071527 | Pneupac VR1 Air Mix | Smiths Medical International, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932170 | Flynnr Genesis II a/C, a/O and IdlhSummary page 1…Genesis H A/C model Ventilator, Emergency, Powered (K932170). Page Smiths Medica Internatonal Lmited -… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2007 | Not classified | Z-0991-2007 | Other | 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 ventilator to stop cycling & to deliver… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (112 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051322: Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051322
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026