Cleared Traditional

MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (K193191) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193191 · Weinmann Emergency Medical Technology GmbH + Co. KG · Anesthesiology device
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Nov 2020
Decision
367d
Days
Class 2
Risk

K193191 is an FDA 510(k) clearance for the MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Weinmann Emergency Medical Technology GmbH + Co. KG (Hamburg, DE). The FDA issued a Cleared decision on November 20, 2020 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Weinmann Emergency Medical Technology GmbH + Co. KG devices

Submission Details

510(k) Number K193191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2019
Decision Date November 20, 2020
Days to Decision 367 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 139d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTL Ventilator, Emergency, Powered (resuscitator)

All 99
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K193191.
VentStar Resus heated (N) (MP17030)
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Oxymag - Transport and Emergency Ventilator
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VORTRAN GO2VENT with PEEP Valve
K202219 · Vortran Medical Technology 1, Inc. · Feb 2021
Puffin Lite Infant Resuscitation System
K182956 · International Biomedical · Jan 2019
SafeT T-Piece Resuscitator
K173373 · Ventlab, LLC · Nov 2018