Cleared Traditional

K874628 - RESUBMITTED STANDARD MICROPORE ECG ELEC...

K874628 is the FDA 510(k) clearance for RESUBMITTED STANDARD MICROPORE ECG ELEC... by Labeltape Meditect, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

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 K874628.
PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
K874422 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424 · Hewlett-Packard Co. · Jan 1988
MACTRODE-II
K872784 · Marquette Electronics, Inc. · Oct 1987
S&W ELECTRODE TYPES 888, 844, 988 AND 944
K864586 · S & W Medico Teknik · Mar 1987
MEDI-TRACE INFANT ELECTRODE
K864722 · Graphic Controls Corp. · Feb 1987