Cleared Traditional

DIFFERENTIAL STETHOSCOPE W/DUAL HEADS (K860473) - FDA 510(k) Clearance

Also marketed or referenced as:
STEREOSCOPE

Class I Cardiovascular device.

K860473 · Schering Corp. · Cardiovascular device
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Aug 1986
Decision
189d
Days
Class 1
Risk

K860473 is an FDA 510(k) clearance for the DIFFERENTIAL STETHOSCOPE W/DUAL HEADS. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by Schering Corp. (Kenilworth, US). The FDA issued a Cleared decision on August 14, 1986 after a review of 189 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 Schering Corp. devices

Submission Details

510(k) Number K860473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1986
Decision Date August 14, 1986
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
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.