Cleared Traditional

K160746 - CARDIOLINE touchECG

K160746 is an FDA 510(k) clearance for CARDIOLINE touchECG, manufactured by Cardioline S.P.A. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K160746 · Cardioline S.P.A · Cardiovascular device
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Nov 2016
Decision
229d
Days
Class 2
Risk

K160746 is an FDA 510(k) clearance for the CARDIOLINE touchECG. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardioline S.P.A (Z.I. Spini Di Gardolo, IT). The FDA issued a Cleared decision on November 2, 2016 after a review of 229 days - an extended review cycle.

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 Cardioline S.P.A devices

FDA 510(k) Submission Details - K160746

510(k) Number K160746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2016
Decision Date November 02, 2016
Days to Decision 229 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
104d slower than avg
Panel avg: 125d · This submission: 229d
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 K160746.
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K171943 · Edan Instruments, Inc. · Sep 2017
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PC ECG
K161302 · Edan Instruments, Inc. · Jul 2016
PC ECG
K152427 · Edan Instruments, Inc. · Feb 2016
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K152944 · Mortara Instrument, Inc. · Jan 2016