Cleared Special

K101639 - CG-6108 ACT-IL CONTINUOUS ECG MONITOR A...

K101639 is an FDA 510(k) clearance for CG-6108 ACT-IL CONTINUOUS ECG MONITOR A..., manufactured by Card Guard Scientific Survival , Ltd.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 15-day FDA review.

K101639 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
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Jun 2010
Decision
15d
Days
Class 2
Risk

K101639 is an FDA 510(k) clearance for the CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Lakewood, US). The FDA issued a Cleared decision on June 25, 2010 after a review of 15 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 Card Guard Scientific Survival , Ltd. devices

FDA 510(k) Submission Details - K101639

510(k) Number K101639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2010
Decision Date June 25, 2010
Days to Decision 15 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
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 238
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K101639.
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
K103764 · Medtronic, Inc. · May 2011
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K110499 · Card Guard Scientific Survival , Ltd. · Apr 2011
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
K101703 · Card Guard Scientific Survival , Ltd. · Jul 2010
INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
K091927 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Nov 2009
EPICARDIA 5000
K090834 · Medicomp, Inc. · May 2009
INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
K083517 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jan 2009