Cleared Traditional

K181998 - CardioBand ECG Event Recorder

K181998 is the FDA 510(k) clearance for CardioBand ECG Event Recorder by Samsung Strategy and Innovation Center (Ssic). It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K181998 · Samsung Strategy and Innovation Center (Ssic) · Cardiovascular device
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Nov 2018
Decision
112d
Days
Class 2
Risk

K181998 is an FDA 510(k) clearance for the CardioBand ECG Event Recorder. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Samsung Strategy and Innovation Center (Ssic) (San Jose, US). The FDA issued a Cleared decision on November 15, 2018 after a review of 112 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 Samsung Strategy and Innovation Center (Ssic) devices

Submission Details

510(k) Number K181998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2018
Decision Date November 15, 2018
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 248
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K181998.
ZOLL ECG Analysis Software
K182093 · Zoll Manufacturing Corporation · Jan 2019
COR12 ECG
K183369 · Corscience GmbH & Co. · Dec 2018
Cardio-TriTest v6.5
K182790 · Cardio-Phoenix, Inc. · Dec 2018
MAC VU360 Resting ECG Analysis System
K173830 · Ge Medical Systems Information Technologies, Inc. · Sep 2018
Universal SmartECG
K173952 · Vectracor, Inc. · Aug 2018
physiQ Heart Rhythm Module
K180234 · Physiq, Inc. · Aug 2018