Cleared Traditional

K920009 - 3M LITTMANN GRAPHIC DISPLAY SYSTEM

K920009 is an FDA 510(k) clearance for 3M LITTMANN GRAPHIC DISPLAY SYSTEM, manufactured by 3M Health Care, Ltd.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K920009 · 3M Health Care, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
293d
Days
Class 2
Risk

K920009 is an FDA 510(k) clearance for the 3M LITTMANN GRAPHIC DISPLAY SYSTEM. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on October 21, 1992 after a review of 293 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 Health Care, Ltd. devices

FDA 510(k) Submission Details - K920009

510(k) Number K920009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date October 21, 1992
Days to Decision 293 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
168d slower than avg
Panel avg: 125d · This submission: 293d
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 108
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K920009.
STETHOS
K963621 · Theratechnologies, Inc. · Dec 1996
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
K961857 · Graham-Field, Inc. · Jul 1996
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
K961301 · Delphi Consulting Group · Jun 1996
MASCOT STETHOSCOPE PROBE
K874726 · Imex Medical Systems, Inc. · Mar 1988
DIF-STET
K832882 · Intersect Systems, Inc. · Dec 1983
CONPHAR SUPERTONE STETHOSCOPE
K801189 · Conphar, Inc. · Jun 1980