Cleared Traditional

K170568 - CardioLogs ECG Analysis Platform

K170568 is an FDA 510(k) clearance for CardioLogs ECG Analysis Platform, manufactured by Cardiologs Technologies. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 119-day FDA review.

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

FDA 510(k) Submission Details - K170568

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.

DPS Device Classification - Class 2, Special Controls

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 283
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
PC ECG
K161302 · Edan Instruments, Inc. · Jul 2016