Cleared Traditional

K170506 - ECG Check - Universal, ECG Check - Universal Plus

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Cjp Consulting, Inc.
Cynthia J. Pillar

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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 234
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K170506.
BioFlux Device
K172311 · Biotricity, Inc. · Dec 2017
Kardia Band System
K171816 · AliveCor, Inc. · Nov 2017
ECG SENTINEL System
K172801 · Cardiomedix, Inc. · Oct 2017
Prizma
K170181 · G-Medical Innovations , Ltd. · Sep 2017
SimplECG
K161431 · Nanowear, Inc. · Nov 2016
Vitaphone Tele ECG Loop Recorder
K151013 · Vitasystems GmbH · Apr 2015