Cleared Traditional

ECG100+, ECG200+ (K160840) - FDA 510(k) Clearance

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

K160840 · Cardioline S.P.A · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
137d
Days
Class 2
Risk

K160840 is an FDA 510(k) clearance for the ECG100+, ECG200+. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardioline S.P.A (Spini Di Gardolo, IT). The FDA issued a Cleared decision on August 12, 2016 after a review of 137 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 Cardioline S.P.A devices

Submission Details

510(k) Number K160840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2016
Decision Date August 12, 2016
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
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 134
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K160840.
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K120770 · Ge Medical Systems Information Technologies · Dec 2012