Cleared Traditional

K102378 - VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI

K102378 is an FDA 510(k) clearance for VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI, manufactured by Vectracor, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K102378 · Vectracor, Inc. · Cardiovascular device
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Nov 2011
Decision
439d
Days
Class 2
Risk

K102378 is an FDA 510(k) clearance for the VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Vectracor, Inc. (Totowa, US). The FDA issued a Cleared decision on November 2, 2011 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Vectracor, Inc. devices

FDA 510(k) Submission Details - K102378

510(k) Number K102378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2010
Decision Date November 02, 2011
Days to Decision 439 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
314d slower than avg
Panel avg: 125d · This submission: 439d
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 280
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K102378.
RSCRIBE ELECTROCARDIOGRAPH
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K110266 · Ge Medical Systems Information Technologies, Inc. · Apr 2011