Cleared Traditional

K821909 - LITTMAN TUNABLE STETHOSCOPE 2136

K821909 is the FDA 510(k) clearance for LITTMAN TUNABLE STETHOSCOPE 2136 by 3M Company. It is a Class 1 Cardiovascular device (product code LDE) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K821909 · 3M Company · Cardiovascular device
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Jul 1982
Decision
16d
Days
Class 1
Risk

K821909 is an FDA 510(k) clearance for the LITTMAN TUNABLE STETHOSCOPE 2136. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 16 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 3M Company devices

Submission Details

510(k) Number K821909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date July 14, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDE Stethoscope, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.1875
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LDE Stethoscope, Manual

Devices cleared under the same product code (LDE) and FDA review panel - the closest regulatory comparables to K821909.
PROSCOPES AND ADSCOPES
K935944 · American Diagnostic Corp. · Mar 1994
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ABCO PEDIATRIC STETHOSCOPE
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