Cleared Traditional

CardioLogs ECG Analysis Platform (K170568) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170568 · Cardiologs Technologies · Cardiovascular device
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Jun 2017
Decision
119d
Days
Class 2
Risk

K170568 is an FDA 510(k) clearance for the CardioLogs ECG Analysis Platform. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardiologs Technologies (Paris, FR). The FDA issued a Cleared decision on June 26, 2017 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

View all Cardiologs Technologies devices

Submission Details

510(k) Number K170568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2017
Decision Date June 26, 2017
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 128
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K170568.
CONTEC™ Electrocardiograph
K171360 · Contec Medical Systems Co.,Ltd · Jan 2018
Digital Electrocardiograph
K171517 · Biocare Bio-Medical Equipment Co., Ltd. · Jan 2018
Electrocardiograph
K171943 · Edan Instruments, Inc. · Sep 2017
Electrocardiograph
K170995 · Edan Instruments, Inc. · Jun 2017
PC ECG
K160876 · Edan Instruments, Inc. · Feb 2017
CP150 ELECTROCARDIOGRAPH
K131573 · Welch Allyn, Inc. · Jul 2013