Cleared Traditional

K904512 - TRACET AG 4000

K904512 is an FDA 510(k) clearance for TRACET AG 4000, manufactured by Lectec Corp.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K904512 · Lectec Corp. · Cardiovascular device
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Jan 1991
Decision
121d
Days
Class 2
Risk

K904512 is an FDA 510(k) clearance for the TRACET AG 4000. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Lectec Corp. (Minnetonka, US). The FDA issued a Cleared decision on January 31, 1991 after a review of 121 days - within the typical 510(k) review window.

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 Lectec Corp. devices

FDA 510(k) Submission Details - K904512

510(k) Number K904512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date January 31, 1991
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
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 92
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K904512.
ECG ELECTRODE
K923558 · Lectec Corp. · Feb 1993
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS
K913226 · Cardiotronics, Inc. · Sep 1991
TRACETS SME 5000
K912450 · Lectec Corp. · Aug 1991
MODEL 1850 ELECTRODE
K903918 · Medtronic Vascular · Oct 1990
SILVER MACTRODE
K902176 · Marquette Electronics, Inc. · Sep 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990