Cleared Traditional

K893425 - VITATRACE

K893425 is an FDA 510(k) clearance for VITATRACE, 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 73-day FDA review.

K893425 · Lectec Corp. · Cardiovascular device
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Jul 1989
Decision
73d
Days
Class 2
Risk

K893425 is an FDA 510(k) clearance for the VITATRACE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Lectec Corp. (Minnetonka, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 73 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 - K893425

510(k) Number K893425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date July 14, 1989
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 K893425.
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