Cleared Traditional

K170506 - ECG Check - Universal

K170506 is an FDA 510(k) clearance for ECG Check - Universal, manufactured by Cardiac Designs, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K170506 · Cardiac Designs, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
223d
Days
Class 2
Risk

K170506 is an FDA 510(k) clearance for the ECG Check - Universal, ECG Check - Universal Plus. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Cardiac Designs, Inc. (Spring, US). The FDA issued a Cleared decision on October 2, 2017 after a review of 223 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Cardiac Designs, Inc. devices

FDA 510(k) Submission Details - K170506

510(k) Number K170506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2017
Decision Date October 02, 2017
Days to Decision 223 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
98d slower than avg
Panel avg: 125d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 123
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K170506.
CARDIOSKIN
K173248 · Bioserenity Sas · Aug 2018
QT ECG
K180157 · QT Medical, Inc. · May 2018
Kardia Band System
K171816 · AliveCor, Inc. · Nov 2017
AliveCor Heart Monitor
K142743 · AliveCor, Inc. · Jan 2015
AliveCor Heart Monitor
K142672 · AliveCor, Inc. · Dec 2014
ALIVECOR HEART MONITOR
K140933 · AliveCor, Inc. · Aug 2014