Cleared Traditional

K101569 - V-TRUST MODEL TD-2202 PORTABLE ECG RECO...

K101569 is the FDA 510(k) clearance for V-TRUST MODEL TD-2202 PORTABLE ECG RECO... by Taidoc Technology Corporation. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K101569 · Taidoc Technology Corporation · Cardiovascular device
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Mar 2011
Decision
270d
Days
Class 2
Risk

K101569 is an FDA 510(k) clearance for the V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on March 1, 2011 after a review of 270 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 Taidoc Technology Corporation devices

Submission Details

510(k) Number K101569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date March 01, 2011
Days to Decision 270 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
145d slower than avg
Panel avg: 125d · This submission: 270d
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 218
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K101569.
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K102854 · Edan Instruments, Inc. · Dec 2010
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K102830 · Edan Instruments, Inc. · Dec 2010