Cleared Traditional

K950537 - CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH

K950537 is an FDA 510(k) clearance for CARDIOPHONICS INCORPORATED DPS 2000 PHO..., manufactured by Cardiophonics, Inc.. The device is a Class 1 Cardiovascular device with product code DQC cleared through the Traditional 510(k) pathway after a 388-day FDA review.

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

FDA 510(k) Submission Details - K950537

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 125d · This submission: 388d
Pathway characteristics
Predicate-based equivalence.

DQC Device Classification - Class 1, General Controls

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.

Regulatory Peers - DQC Phonocardiograph

Devices cleared under the same product code (DQC) and FDA review panel - the closest regulatory comparables to K950537.
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE
K900560 · Acuson Corp. · Dec 1990
MEDDARS/ULTRA IMAGER PULSE/PHON MODULE
K811626 · Honeywell, Inc. · Jul 1981
NIC-200 VENTRICULAR FUNCTION ANALYZER
K792466 · Nicolet Biomedical Instruments · Jan 1980
AMPLIFIER, PC-700
K780116 · Burdick Corp. · Feb 1978
PULSE/PHONOCARDIOGRAPHY CHANNEL, 144
K770757 · Honeywell, Inc. · May 1977
PHON/STRESS SYSTEM (#21126A)
K760464 · Hewlett-Packard Co. · Aug 1976