Cleared Traditional

K874628 - RESUBMITTED STANDARD MICROPORE ECG ELECTRODE

K874628 is an FDA 510(k) clearance for RESUBMITTED STANDARD MICROPORE ECG ELEC..., manufactured by Labeltape Meditect, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K874628 · Labeltape Meditect, Inc. · Cardiovascular device
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Dec 1987
Decision
46d
Days
Class 2
Risk

K874628 is an FDA 510(k) clearance for the RESUBMITTED STANDARD MICROPORE ECG ELECTRODE. 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 December 7, 1987 after a review of 46 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

FDA 510(k) Submission Details - K874628

510(k) Number K874628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1987
Decision Date December 07, 1987
Days to Decision 46 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
79d faster than avg
Panel avg: 125d · This submission: 46d
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 181
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K874628.
FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE
K875041 · Labeltape Meditect, Inc. · Jan 1988
TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE)
K874437 · Labeltape Meditect, Inc. · Dec 1987
FERRIS ECG ELECTRODE W/HYDROGEL
K873682 · Ferris Mfg. Corp. · Dec 1987
NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)
K872871 · Labeltape Meditect, Inc. · Oct 1987
MACTRODE-II
K872784 · Marquette Electronics, Inc. · Oct 1987
MD MONITORING/DIAGNOSTIC ELECTRODE
K870873 · Lectec Corp. · Apr 1987