Cleared Traditional

K934000 - SENTRY AQUEOUS GEL ECG ELECTRODES

K934000 is the FDA 510(k) clearance for SENTRY AQUEOUS GEL ECG ELECTRODES by Sentry Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K934000 · Sentry Medical Products, Inc. · Cardiovascular device
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Aug 1994
Decision
378d
Days
Class 2
Risk

K934000 is an FDA 510(k) clearance for the SENTRY AQUEOUS GEL ECG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Sentry Medical Products, Inc. (Lombard, US). The FDA issued a Cleared decision on August 30, 1994 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentry Medical Products, Inc. devices

Submission Details

510(k) Number K934000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date August 30, 1994
Days to Decision 378 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 125d · This submission: 378d
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 K934000.
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
K950487 · Graphic Controls Corp. · May 1995
QUIK COMBO
K943301 · Physio-Control Corp. · Feb 1995
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214 · Graphic Controls Corp. · Nov 1994
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312 · 3M Health Care, Ltd. · Sep 1993
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454 · 3M Health Care, Ltd. · Aug 1993
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993