510(k) · Cleared
ClearedMEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weinmann Emergency Medical Technology GmbH + Co. KG · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Nov 20, 2020 as substantially equivalent to K051322 (Smiths Medical International, Ltd., 2005) after a 367-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Nov 20, 2020
- Review
- 367 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932170 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK932170 Flynnr Genesis II a/C, a/O and IdlhO-Two Systems Intl., Inc. · 1993
- 1 generation backK051322 Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model…Smiths Medical International, Ltd. · 2005 · Recalled
- This deviceK193191 MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932170 | Flynnr Genesis II a/C, a/O and Idlh | O-Two Systems Intl., Inc. | 1993 | — |
| −1 | K051322 | Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus | Smiths Medical International, Ltd. | 2005 | 1 |
| 0 (this device) | K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020 | — |
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 |
|---|---|---|---|
| * | K051322 | Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model VriresnusSummary page 4…Classification Name Ventilator, Emergency, Powered (Resuscita- tor) 510(k) number K051322 Device Name Pneupac VR1 Standard Applicant Smiths Medical Interna… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K051322.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilator used for ventilation and oxygen inhalation with either a mask or tube.
Patient groups
Adults and children with a body weight of over 22 lbs (10 kg) where spontaneous respiration has failed or is inadequate.
Users
Qualified medical personnel only
Intended environments of use
• Mobile use for emergency medicine and primary care during emergency deployments
• During land or air transport or transfer between hospital rooms and departments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193191: MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193191
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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