Cleared Traditional

K050443 - ACCU-LEAD

K050443 is an FDA 510(k) clearance for ACCU-LEAD, manufactured by Kentec Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K050443 · Kentec Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2005
Decision
192d
Days
Class 2
Risk

K050443 is an FDA 510(k) clearance for the ACCU-LEAD. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Kentec Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on September 2, 2005 after a review of 192 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 Kentec Medical, Inc. devices

FDA 510(k) Submission Details - K050443

510(k) Number K050443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date September 02, 2005
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
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 186
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K050443.
AMBU BLUE SENSOR NEO AND NEO X
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ELECTRODE
K050248 · Electramold · May 2005
ACCUHEART ELECTRODE BELT
K043361 · Advanced Bioelectric Corporation · Mar 2005
AMBU DISPOSABLE ECG ELECTRODE
K041734 · Ambu, Inc. · Sep 2004