Cleared Traditional

K854771 - SALTZMAN STETHOSCOPE HEAD

K854771 is the FDA 510(k) clearance for SALTZMAN STETHOSCOPE HEAD by K & S Medicorp. It is a Class 1 Cardiovascular device (product code LDE) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K854771 · K & S Medicorp · Cardiovascular device
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May 1986
Decision
161d
Days
Class 1
Risk

K854771 is an FDA 510(k) clearance for the SALTZMAN STETHOSCOPE HEAD. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by K & S Medicorp (Miami, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 161 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.

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Submission Details

510(k) Number K854771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1985
Decision Date May 09, 1986
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
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 K854771.
LITTMAN TUNABLE STETHOSCOPE 2136
K821909 · 3M Company · Jul 1982
CONPHAR DUAL HEAD STETHOSCOPE
K801183 · Conphar, Inc. · Jun 1980
CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE
K801184 · Conphar, Inc. · Jun 1980
CONPHAR BOWLS STETHOSCOPE
K801185 · Conphar, Inc. · Jun 1980
ABCO PEDIATRIC STETHOSCOPE
K801215 · Abco Dealers, Inc. · Jun 1980