Cleared Traditional

K083903 - 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200

K083903 is an FDA 510(k) clearance for 3M LITTMANN ELECTRONIC STETHOSCOPE, manufactured by 3M Company. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K083903 · 3M Company · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
198d
Days
Class 2
Risk

K083903 is an FDA 510(k) clearance for the 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on July 15, 2009 after a review of 198 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 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 3M Company devices

FDA 510(k) Submission Details - K083903

510(k) Number K083903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date July 15, 2009
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
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 87
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K083903.
SENSI
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K103516 · Inovise Medical, Inc. · Feb 2011
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · American Diagnostic Corp. · May 2006
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · 3M Company · Jul 2005
HL 200 ELECTRONIC STETHOSCOPE
K050169 · Health & Life Co., Ltd. · Apr 2005