Cleared Traditional

K963621 - STETHOS

K963621 is an FDA 510(k) clearance for STETHOS, manufactured by Theratechnologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K963621 · Theratechnologies, Inc. · Cardiovascular device
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Dec 1996
Decision
89d
Days
Class 2
Risk

K963621 is an FDA 510(k) clearance for the STETHOS. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Theratechnologies, Inc. (Montreal, Quebec, CA). The FDA issued a Cleared decision on December 4, 1996 after a review of 89 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.

View all Theratechnologies, Inc. devices

FDA 510(k) Submission Details - K963621

510(k) Number K963621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1996
Decision Date December 04, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
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 63
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K963621.
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K041934 · 3M Company · Oct 2004
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · American Diagnostic Corp. · Nov 2001
3M LITTMANN
K003723 · 3M Company · Mar 2001
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