Cleared Traditional

K011564 - NEOLEAD

K011564 is an FDA 510(k) clearance for NEOLEAD, manufactured by Neotech Products, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K011564 · Neotech Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
227d
Days
Class 2
Risk

K011564 is an FDA 510(k) clearance for the NEOLEAD. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Neotech Products, Inc. (Chatsworth, US). The FDA issued a Cleared decision on January 3, 2002 after a review of 227 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 Neotech Products, Inc. devices

FDA 510(k) Submission Details - K011564

510(k) Number K011564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date January 03, 2002
Days to Decision 227 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
102d slower than avg
Panel avg: 125d · This submission: 227d
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 176
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K011564.
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V QUICK PATCH
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