Cleared Traditional

K894462 - CARE DISP. DIAG. ELECTRODES

K894462 is the FDA 510(k) clearance for CARE DISP. DIAG. ELECTRODES by Labeltape Meditect, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K894462 · Labeltape Meditect, Inc. · Cardiovascular device
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Oct 1989
Decision
86d
Days
Class 2
Risk

K894462 is an FDA 510(k) clearance for the CARE DISP. DIAG. ELECTRODES, SILVER/SILVER. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on October 12, 1989 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 Labeltape Meditect, Inc. devices

Submission Details

510(k) Number K894462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date October 12, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

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 83
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K894462.
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K884980 · S & W Medico Teknik · May 1989
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K891075 · C.R. Bard, Inc. · Mar 1989