Cleared Traditional

K941977 - TAYLOR LONG TERM MONITORING ELECTRODE

K941977 is an FDA 510(k) clearance for TAYLOR LONG TERM MONITORING ELECTRODE, manufactured by Taylor Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K941977 · Taylor Industries, Inc. · Cardiovascular device
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Sep 1994
Decision
155d
Days
Class 2
Risk

K941977 is an FDA 510(k) clearance for the TAYLOR LONG TERM MONITORING ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Taylor Industries, Inc. (New Berlin, US). The FDA issued a Cleared decision on September 21, 1994 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K941977

510(k) Number K941977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1994
Decision Date September 21, 1994
Days to Decision 155 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
30d slower than avg
Panel avg: 125d · This submission: 155d
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 296
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K941977.
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214 · Graphic Controls Corp. · Nov 1994
ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES
K935429 · Arbo Medical, Inc. · Nov 1994
2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE
K944849 · Conmed Andover Medical, Inc. · Oct 1994
ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES
K935281 · Arbo Medical, Inc. · Sep 1994
SENTRY AQUEOUS GEL ECG ELECTRODES
K934000 · Sentry Medical Products, Inc. · Aug 1994
K-KLIP
K940801 · Katecho, Inc. · Aug 1994
K941977 · TAYLOR LONG TERM MONITORING ELECTRODE
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