Cleared Traditional

CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH (K950537) - FDA 510(k) Clearance

Class I Cardiovascular device.

K950537 · Cardiophonics, Inc. · Cardiovascular device
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Mar 1996
Decision
388d
Days
Class 1
Risk

K950537 is an FDA 510(k) clearance for the CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Cardiophonics, Inc. (Port Jefferson Station, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Cardiophonics, Inc. devices

Submission Details

510(k) Number K950537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1995
Decision Date March 01, 1996
Days to Decision 388 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
263d slower than avg
Panel avg: 125d · This submission: 388d
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.