Cleared Traditional

ELECTROCARDIOGRAPHIC ECG RECORDER (K781152) - FDA 510(k) Clearance

Class I Cardiovascular device.

K781152 · Cardio-Dynamics Laboratories, Inc. · Cardiovascular device
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Aug 1978
Decision
52d
Days
Class 1
Risk

K781152 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPHIC ECG RECORDER. Classified as Alarm, Leakage Current, Portable (product code DSM), Class I - General Controls.

Submitted by Cardio-Dynamics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2640 - 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 K781152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1978
Decision Date August 31, 1978
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DSM Alarm, Leakage Current, Portable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.