Cleared Traditional

K152863 - Portable ECG Monitor

K152863 is an FDA 510(k) clearance for Portable ECG Monitor, manufactured by Contec Medical Systems Co.,Ltd. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K152863 · Contec Medical Systems Co.,Ltd · Cardiovascular device
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Jun 2016
Decision
266d
Days
Class 2
Risk

K152863 is an FDA 510(k) clearance for the Portable ECG Monitor. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on June 22, 2016 after a review of 266 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 Contec Medical Systems Co.,Ltd devices

FDA 510(k) Submission Details - K152863

510(k) Number K152863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date June 22, 2016
Days to Decision 266 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
141d slower than avg
Panel avg: 125d · This submission: 266d
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 Consultant

Mid-Link Consulting Co, Ltd.
DIANA HONG

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 - DPS Electrocardiograph

All 466
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K152863.
ECG100+, ECG200+
K160840 · Cardioline S.P.A · Aug 2016
Quantitative Electrocardiographic Detector (QED 2000)
K152135 · Acme Portable Machines, Inc. · Aug 2016
PC ECG
K161302 · Edan Instruments, Inc. · Jul 2016
Diagnostic Station DS20
K152043 · Schiller AG · May 2016
MODEL 621/624 BIOMAGNETOMETER
K151135 · Tristan Technologies, Inc. · Mar 2016
ANI Monitor
K142969 · Mdoloris Medical Systems Sas · Feb 2016