Cleared Traditional

ECG ELECTRODE, 2021, 2022, 2032, 2033 (K781514) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K781514 · Cardio-Dynamics Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
46d
Days
Class 2
Risk

K781514 is an FDA 510(k) clearance for the ECG ELECTRODE, 2021, 2022, 2032, 2033. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Cardio-Dynamics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978 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 Cardio-Dynamics Laboratories, Inc. devices

Submission Details

510(k) Number K781514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1978
Decision Date October 17, 1978
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 25
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K781514.
QUINTON LTE ELECTRODE
K810563 · Quinton, Inc. · Mar 1981
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040 · C.R. Bard, Inc. · Nov 1979
ELECTRODE SYSTEM, QUIK-PREP
K782079 · Quinton, Inc. · Feb 1979
ELECTRODE, DEIP.
K781163 · Datascope Corp. · Sep 1978
ECG CLUSTER ELECTRODE
K771776 · C.R. Bard, Inc. · Nov 1977