Cleared Traditional

K934000 - SENTRY AQUEOUS GEL ECG ELECTRODES

K934000 is an FDA 510(k) clearance for SENTRY AQUEOUS GEL ECG ELECTRODES, manufactured by Sentry Medical Products, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K934000

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.

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 186
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K934000.
QUIK COMBO
K943301 · Physio-Control Corp. · Feb 1995
TRIGEL MULTIFUNCTION ELECTRODE
K934505 · Physiometrix, Inc. · Nov 1994
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214 · Graphic Controls Corp. · Nov 1994
K-KLIP
K940801 · Katecho, Inc. · Aug 1994
ZIPPREP ELECTRODE
K940802 · Aspect Medical Systems, Inc. · Jun 1994
K-SNAP
K940586 · Katecho, Inc. · Jun 1994