Cleared Traditional

K091972 - MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01

K091972 is an FDA 510(k) clearance for MILSCOPE FLOATING MASS STETHOSCOPE, manufactured by Stethoscope Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K091972 · Stethoscope Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
84d
Days
Class 2
Risk

K091972 is an FDA 510(k) clearance for the MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Stethoscope Technologies, Inc. (Mill Valley, US). The FDA issued a Cleared decision on September 23, 2009 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K091972

510(k) Number K091972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date September 23, 2009
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 141
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K091972.
AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
K103516 · Inovise Medical, Inc. · Feb 2011
PCP/PC STETHOSCOPE
K102893 · Rnk Products, Inc. · Jan 2011
VISCOPE, MODEL 100P,100S
K100531 · Hd Medical Services (India) Pvt.Ltd · Jul 2010
SIGNAL
K090493 · Zargis Medical Corp. · Aug 2009
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · 3M Company · Jul 2009
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
K082528 · Noble Anesthesia-Air, Inc. · Mar 2009
K091972 · MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
Download PDF Stethoscope Technolog…