Cleared Traditional

CONTEC™ Electrocardiograph (K171360) - FDA 510(k) Clearance

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

K171360 · Contec Medical Systems Co.,Ltd · Cardiovascular device
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Jan 2018
Decision
258d
Days
Class 2
Risk

K171360 is an FDA 510(k) clearance for the CONTEC™ Electrocardiograph. 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 January 22, 2018 after a review of 258 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

Submission Details

510(k) Number K171360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date January 22, 2018
Days to Decision 258 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
133d slower than avg
Panel avg: 125d · This submission: 258d
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 Consultant

Beijing Believe Technology Service Co., Ltd.
Ray Wang

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 126
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K171360.
HeRO Symphony, HeRO ES, HeRO solo/duet
K180242 · Medical Predictive Science Corporation · Feb 2018
MiCor A100 Wearable ECG Recorder
K162665 · Mitac International Corp. · Jan 2018
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K171942 · Edan Instruments, Inc. · Jan 2018
Digital Electrocardiograph
K171517 · Biocare Bio-Medical Equipment Co., Ltd. · Jan 2018
Electrocardiograph
K171943 · Edan Instruments, Inc. · Sep 2017
Electrocardiograph
K170995 · Edan Instruments, Inc. · Jun 2017