Cleared Traditional

DYNAMIC ECG SYSTEM MODEL TLC5000 (K101273) - FDA 510(k) Clearance

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

K101273 · Contec Medical System Co., Ltd. · Cardiovascular device
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Sep 2011
Decision
512d
Days
Class 2
Risk

K101273 is an FDA 510(k) clearance for the DYNAMIC ECG SYSTEM MODEL TLC5000. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Contec Medical System Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 30, 2011 after a review of 512 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Contec Medical System Co., Ltd. devices

Submission Details

510(k) Number K101273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2010
Decision Date September 30, 2011
Days to Decision 512 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
387d slower than avg
Panel avg: 125d · This submission: 512d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 31
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