Cleared Abbreviated

K124060 - MEDICAL GORITHMICS UNIFIED ARRHYTHMIA D...

K124060 is an FDA 510(k) clearance for MEDICAL GORITHMICS UNIFIED ARRHYTHMIA D..., manufactured by Medicalgorithmics S.A.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Abbreviated 510(k) pathway after a 52-day FDA review.

K124060 · Medicalgorithmics S.A. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
52d
Days
Class 2
Risk

K124060 is an FDA 510(k) clearance for the MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Medicalgorithmics S.A. (New York, US). The FDA issued a Cleared decision on February 21, 2013 after a review of 52 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medicalgorithmics S.A. devices

FDA 510(k) Submission Details - K124060

510(k) Number K124060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2012
Decision Date February 21, 2013
Days to Decision 52 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Standards-based clearance path.

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
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K124060.
IntelliVue Patient Monitor
K151681 · Philips Medizin Systeme Boeblingen GmbH · Jul 2015
Medtronic Patient Asistant
K150117 · Medtronic, Inc. · May 2015
IntelliVue Patient Monitor
K150310 · Philips Medizin Systeme Boeblingen GmbH · May 2015
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
K120774 · Welch Allyn, Inc. · Apr 2012
INTELLIVUE MX40 PATIENT MONITOR
K113125 · Philips Medical Systems · Nov 2011
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
K103764 · Medtronic, Inc. · May 2011