Cleared Traditional

VARIOUS STETHOSCOPES (K944337) - FDA 510(k) Clearance

Class I Cardiovascular device.

K944337 · Rud Riester GmbH & CO KG · Cardiovascular device
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Nov 1994
Decision
85d
Days
Class 1
Risk

K944337 is an FDA 510(k) clearance for the VARIOUS STETHOSCOPES. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by Rud Riester GmbH & CO KG (Jungingen, DE). The FDA issued a Cleared decision on November 30, 1994 after a review of 85 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 Rud Riester GmbH & CO KG devices

Submission Details

510(k) Number K944337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1994
Decision Date November 30, 1994
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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.