Cleared Abbreviated

HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300 (K021087) - FDA 510(k) Clearance

Also marketed or referenced as:
SOUNDS EASY AUSCULTATION SOFTWARE

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K021087 · Erecords Limited · Cardiovascular device
Download Printable Device Report (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.

View all Erecords Limited devices

Submission Details

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
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 52
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K021087.
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · 3M Company · Jul 2005
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K050159 · 3M Company · Feb 2005
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K041934 · 3M Company · Oct 2004
3M LITTMANN
K003723 · 3M Company · Mar 2001
ELECTRONIC STETHOSCOPE
K771653 · 3M Company · Sep 1977