Cleared Traditional

K153477 - EMMa Electronic Monitoring Management

K153477 is an FDA 510(k) clearance for EMMa Electronic Monitoring Management, manufactured by Vitasystems GmbH. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K153477 · Vitasystems GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
175d
Days
Class 2
Risk

K153477 is an FDA 510(k) clearance for the EMMa Electronic Monitoring Management. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Vitasystems GmbH (Mannheim, DE). The FDA issued a Cleared decision on May 25, 2016 after a review of 175 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 Vitasystems GmbH devices

FDA 510(k) Submission Details - K153477

510(k) Number K153477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2015
Decision Date May 25, 2016
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 262
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K153477.
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