Cleared Traditional

DSP100 AMPLIFIER (K860814) - FDA 510(k) Clearance

Class I Cardiovascular device.

K860814 · Intl. Acoustics, Inc. · Cardiovascular device
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Dec 1986
Decision
276d
Days
Class 1
Risk

K860814 is an FDA 510(k) clearance for the DSP100 AMPLIFIER. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Intl. Acoustics, Inc. (Palatine, US). The FDA issued a Cleared decision on December 5, 1986 after a review of 276 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

Submission Details

510(k) Number K860814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date December 05, 1986
Days to Decision 276 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 125d · This submission: 276d
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.