Cleared Special

K051790 - 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100

K051790 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 Special 510(k) pathway after a 24-day FDA review.

K051790 · 3M Company · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
24d
Days
Class 2
Risk

K051790 is an FDA 510(k) clearance for the 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100. 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 25, 2005 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all 3M Company devices

FDA 510(k) Submission Details - K051790

510(k) Number K051790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2005
Decision Date July 25, 2005
Days to Decision 24 days
Submission Type Special
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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 101
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K051790.
HEART STG SYSTEM AND SOFTWARE
K052283 · Stethographics, Inc. · Dec 2005
EXTENDED MEASUREMENTS SYSTEM
K051450 · Inovise Medical, Inc. · Nov 2005
TECHNO-SCOPE VISUAL STETHOSCOPE
K050097 · Techtrade, LLC · Sep 2005
HL 200 ELECTRONIC STETHOSCOPE
K050169 · Health & Life Co., Ltd. · Apr 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