Cleared Traditional

K781163 - ELECTRODE

K781163 is the FDA 510(k) clearance for ELECTRODE by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K781163 · Datascope Corp. · Cardiovascular device
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Sep 1978
Decision
76d
Days
Class 2
Risk

K781163 is an FDA 510(k) clearance for the ELECTRODE, DEIP.. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1978 after a review of 76 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 Datascope Corp. devices

Submission Details

510(k) Number K781163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1978
Decision Date September 26, 1978
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
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 74
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K781163.
LIFEPATCH ECG ELECTRODES
K790959 · Physio-Control Corp. · May 1979
ELECTRODE SYSTEM, QUIK-PREP
K782079 · Quinton, Inc. · Feb 1979
ELECTRODES, OFFSET AND DX
K781963 · Graphic Controls Corp. · Dec 1978
ECG CLUSTER ELECTRODE
K771776 · C.R. Bard, Inc. · Nov 1977
LIFEPATCH TM ECG ELECTRODE
K770083 · Physio-Control Corp. · Feb 1977
RADIO TRANSPARENT ECG ELECTRODE
K761249 · Concept, Inc. · Dec 1976