Cleared Traditional

K143359 - CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector

K143359 is an FDA 510(k) clearance for CG-6108 ACT-3L Continuous ECG Monitor a..., manufactured by Lifewatch Technologies , Ltd.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K143359 · Lifewatch Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
291d
Days
Class 2
Risk

K143359 is an FDA 510(k) clearance for the CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Lifewatch Technologies , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on September 11, 2015 after a review of 291 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.

FDA 510(k) Submission Details - K143359

510(k) Number K143359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2014
Decision Date September 11, 2015
Days to Decision 291 days
Submission Type Traditional
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
166d slower than avg
Panel avg: 125d · This submission: 291d
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 Consultant

Life Watch
Stephen Slavens

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DSI Detector And Alarm, Arrhythmia

All 321
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K143359.
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