Cleared Traditional

K993934 - V QUICK PATCH

K993934 is an FDA 510(k) clearance for V QUICK PATCH, manufactured by Vq Corp.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K993934 · Vq Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
271d
Days
Class 2
Risk

K993934 is an FDA 510(k) clearance for the V QUICK PATCH. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Vq Corp. (Cincinnati, US). The FDA issued a Cleared decision on August 15, 2000 after a review of 271 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Vq Corp. devices

FDA 510(k) Submission Details - K993934

510(k) Number K993934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1999
Decision Date August 15, 2000
Days to Decision 271 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
146d slower than avg
Panel avg: 125d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 175
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K993934.
SKINTACT ECG ELECTRODE
K023503 · Leonhard Lang GmbH · Nov 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · Bio Protech, Inc. · Nov 2002
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · Cambridge Heart, Inc. · Aug 2000
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
K990110 · Maersk Medical A/S · Dec 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
K990111 · Maersk Medical A/S · Dec 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
K990112 · Maersk Medical A/S · Dec 1999