Cleared Traditional

K151269 - ECG Mini System Continuous ECG Monitor and Arrhythmia Detector

K151269 is an FDA 510(k) clearance for ECG Mini System Continuous ECG Monitor ..., 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 247-day FDA review.

K151269 · Lifewatch Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
247d
Days
Class 2
Risk

K151269 is an FDA 510(k) clearance for the ECG Mini System 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 January 15, 2016 after a review of 247 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 - K151269

510(k) Number K151269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2015
Decision Date January 15, 2016
Days to Decision 247 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
122d slower than avg
Panel avg: 125d · This submission: 247d
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

Biologics Consulting Group, Inc.
Donna-Bea Tillman

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 K151269.
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