Cleared Traditional

MENNTOR X7 (K141441) - FDA 510(k) Clearance

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

K141441 · Mennen Medical , Ltd. · Cardiovascular device
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Jan 2015
Decision
221d
Days
Class 2
Risk

K141441 is an FDA 510(k) clearance for the MENNTOR X7. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Mennen Medical , Ltd. (Yavne, IL). The FDA issued a Cleared decision on January 9, 2015 after a review of 221 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Mennen Medical , Ltd. devices

Submission Details

510(k) Number K141441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2014
Decision Date January 09, 2015
Days to Decision 221 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 125d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSI Detector And Alarm, Arrhythmia

All 100
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