Cleared Traditional

K990809 - CADISCOPE ELECTRONIC STETHOSCOPE

K990809 is an FDA 510(k) clearance for CADISCOPE ELECTRONIC STETHOSCOPE, manufactured by Caditec AG. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K990809 · Caditec AG · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1999
Decision
90d
Days
Class 2
Risk

K990809 is an FDA 510(k) clearance for the CADISCOPE ELECTRONIC STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Caditec AG (Mundelein, US). The FDA issued a Cleared decision on June 9, 1999 after a review of 90 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 Caditec AG devices

FDA 510(k) Submission Details - K990809

510(k) Number K990809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1999
Decision Date June 09, 1999
Days to Decision 90 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 66
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K990809.
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
MEDITRON STETHOSCOPE SYSTEM
K991367 · Meditron AS · Jul 1999
3M LITTMANN GRAPHIC DISPLAY SYSTEM
K920009 · 3M Health Care, Ltd. · Oct 1992
MASCOT STETHOSCOPE PROBE
K874726 · Imex Medical Systems, Inc. · Mar 1988
DIF-STET
K832882 · Intersect Systems, Inc. · Dec 1983