Cleared Abbreviated

K021389 - BIOLOGICAL SOUND MONITOR (BSM) SENSOR

K021389 is an FDA 510(k) clearance for BIOLOGICAL SOUND MONITOR (BSM) SENSOR, manufactured by Andromed, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Abbreviated 510(k) pathway after a 152-day FDA review.

K021389 · Andromed, Inc. · Cardiovascular device
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Oct 2002
Decision
152d
Days
Class 2
Risk

K021389 is an FDA 510(k) clearance for the BIOLOGICAL SOUND MONITOR (BSM) SENSOR. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Andromed, Inc. (Saint Laurent, Quebec, CA). The FDA issued a Cleared decision on October 1, 2002 after a review of 152 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K021389

510(k) Number K021389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2002
Decision Date October 01, 2002
Days to Decision 152 days
Submission Type Abbreviated
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
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Standards-based clearance path.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQD Stethoscope, Electronic

All 127
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K021389.
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
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HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300
K021087 · Erecords Limited · Oct 2002
I-STETHOS LINK
K022298 · Andromed, Inc. · Oct 2002
MEDITRON II THESTERTHOSCOPE SYSTEM
K013725 · Meditron AS · Jan 2002
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · American Diagnostic Corp. · Nov 2001