Cleared Traditional

DYNAMIC SPECTRAL PHONOCARDIOGRAPH (K902185) - FDA 510(k) Clearance

Class I Cardiovascular device.

K902185 · Reeves Scientific, Inc. · Cardiovascular device
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Mar 1991
Decision
315d
Days
Class 1
Risk

K902185 is an FDA 510(k) clearance for the DYNAMIC SPECTRAL PHONOCARDIOGRAPH. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Reeves Scientific, Inc. (New Haven, US). The FDA issued a Cleared decision on March 25, 1991 after a review of 315 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 Reeves Scientific, Inc. devices

Submission Details

510(k) Number K902185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1990
Decision Date March 25, 1991
Days to Decision 315 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 125d · This submission: 315d
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.