Cleared Abbreviated

K021087 - HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300

Also marketed or referenced as:
SOUNDS EASY AUSCULTATION SOFTWARE

K021087 is an FDA 510(k) clearance for HIPPOCRAT ELECTRONIC STETHOSCOPE, manufactured by Erecords Limited. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Abbreviated 510(k) pathway after a 191-day FDA review.

K021087 · Erecords Limited · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
191d
Days
Class 2
Risk

K021087 is an FDA 510(k) clearance for the HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Erecords Limited (Toronto, CA). The FDA issued a Cleared decision on October 11, 2002 after a review of 191 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 - K021087

510(k) Number K021087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2002
Decision Date October 11, 2002
Days to Decision 191 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
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 155
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K021087.
JABES ELECTRONIC STETHOSCOPE
K031446 · Gs Technology Co., Ltd. · Oct 2003
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
K023759 · Sonomedica · May 2003
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
K023637 · Tytan Medical Corp. · Feb 2003
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
K021389 · Andromed, Inc. · Oct 2002
I-STETHOS LINK
K022298 · Andromed, Inc. · Oct 2002
MEDITRON II THESTERTHOSCOPE SYSTEM
K013725 · Meditron AS · Jan 2002
K021087 · HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300
Download PDF FDA Summary Erecords Limited