Cleared Traditional

ACOUSTIC RECORDER (K943726) - FDA 510(k) Clearance

Class I Cardiovascular device.

K943726 · Technology Applications Assoc., Inc. · Cardiovascular device
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Nov 1994
Decision
120d
Days
Class 1
Risk

K943726 is an FDA 510(k) clearance for the ACOUSTIC RECORDER. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Technology Applications Assoc., Inc. (San Diego, US). The FDA issued a Cleared decision on November 30, 1994 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2390 - 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. Standard predicate reliance. 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 Technology Applications Assoc., Inc. devices

Submission Details

510(k) Number K943726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1994
Decision Date November 30, 1994
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQC Phonocardiograph
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2390
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.