Cleared Traditional

K912450 - TRACETS SME 5000

K912450 is an FDA 510(k) clearance for TRACETS SME 5000, 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 86-day FDA review.

K912450 · Lectec Corp. · Cardiovascular device
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Aug 1991
Decision
86d
Days
Class 2
Risk

K912450 is an FDA 510(k) clearance for the TRACETS SME 5000. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Lectec Corp. (Minnetonka, US). The FDA issued a Cleared decision on August 28, 1991 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lectec Corp. devices

FDA 510(k) Submission Details - K912450

510(k) Number K912450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date August 28, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
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 K912450.
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993
ECG ELECTRODE
K923558 · Lectec Corp. · Feb 1993
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS
K913226 · Cardiotronics, Inc. · Sep 1991
TRACET AG 4000
K904512 · Lectec Corp. · Jan 1991
MODEL 1850 ELECTRODE
K903918 · Medtronic Vascular · Oct 1990
SILVER MACTRODE
K902176 · Marquette Electronics, Inc. · Sep 1990