Cleared Traditional

K890126 - KAMED STETHOSCOPE (FDA 510(k) Clearance)

Class I Cardiovascular device.

K890126 · D.R.G. · Cardiovascular device
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Apr 1989
Decision
99d
Days
Class 1
Risk

K890126 is an FDA 510(k) clearance for the KAMED STETHOSCOPE. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by D.R.G. (Mountainside, US). The FDA issued a Cleared decision on April 21, 1989 after a review of 99 days - within the typical 510(k) review window.

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 K890126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1989
Decision Date April 21, 1989
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
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.