Cleared Traditional

K001788 - ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200

K001788 is an FDA 510(k) clearance for ESTATION ELECTRONIC STETHOSCOPE, manufactured by Erecords Enterprises. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K001788 · Erecords Enterprises · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
143d
Days
Class 2
Risk

K001788 is an FDA 510(k) clearance for the ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Erecords Enterprises (Toronto, CA). The FDA issued a Cleared decision on November 3, 2000 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 Erecords Enterprises devices

FDA 510(k) Submission Details - K001788

510(k) Number K001788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2000
Decision Date November 03, 2000
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 95
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K001788.
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
K042128 · Zargis Medical Corp. · Sep 2004
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · American Diagnostic Corp. · Nov 2001
3M LITTMANN
K003723 · 3M Company · Mar 2001
GEMINI E
K993623 · Allen Medical Instruments Corp. · Jun 2000
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
K991714 · Doctor'S Research Group, Inc. · Dec 1999
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
K991756 · Bio-Research Associates, Inc. · Dec 1999