Cleared Traditional

K181998 - CardioBand ECG Event Recorder

K181998 is an FDA 510(k) clearance for CardioBand ECG Event Recorder, manufactured by Samsung Strategy and Innovation Center (Ssic). The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K181998

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.

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 403
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