Cleared Traditional

LIFE SOUND SENSOR (K952651) - FDA 510(k) Clearance

Class I Cardiovascular device.

K952651 · Flowscan, Inc. · Cardiovascular device
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Sep 1995
Decision
102d
Days
Class 1
Risk

K952651 is an FDA 510(k) clearance for the LIFE SOUND SENSOR. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Flowscan, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 102 days - within the typical 510(k) review window.

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 Flowscan, Inc. devices

Submission Details

510(k) Number K952651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1995
Decision Date September 19, 1995
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
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.