Cleared Traditional

K864429 - DSP100 CAROTID PHONOANGIOGRAPHY MODULE

K864429 is an FDA 510(k) clearance for DSP100 CAROTID PHONOANGIOGRAPHY MODULE, manufactured by Intl. Acoustics, Inc.. The device is a Class 1 Cardiovascular device with product code DQC cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K864429 · Intl. Acoustics, Inc. · Cardiovascular device
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May 1987
Decision
181d
Days
Class 1
Risk

K864429 is an FDA 510(k) clearance for the DSP100 CAROTID PHONOANGIOGRAPHY MODULE. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Intl. Acoustics, Inc. (Palatine, US). The FDA issued a Cleared decision on May 12, 1987 after a review of 181 days - an extended review cycle.

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 Intl. Acoustics, Inc. devices

FDA 510(k) Submission Details - K864429

510(k) Number K864429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date May 12, 1987
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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

All 7
Devices cleared under the same product code (DQC) and FDA review panel - the closest regulatory comparables to K864429.
CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH
K950537 · Cardiophonics, Inc. · Mar 1996
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