Cleared Special

K152550 - MEDICALGORITHMICS UNIFIED ARRHYTHMIA DI...

K152550 is an FDA 510(k) clearance for MEDICALGORITHMICS UNIFIED ARRHYTHMIA DI..., manufactured by Medicalgorithmics S.A.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 30-day FDA review.

K152550 · Medicalgorithmics S.A. · Cardiovascular device
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Oct 2015
Decision
30d
Days
Class 2
Risk

K152550 is an FDA 510(k) clearance for the MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on October 8, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medicalgorithmics S.A. devices

FDA 510(k) Submission Details - K152550

510(k) Number K152550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2015
Decision Date October 08, 2015
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 239
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