Cleared Traditional

STETHOSCOPE COVER (K923327) - FDA 510(k) Clearance

Class I Cardiovascular device.

K923327 · Anup Chakraborty Co. · Cardiovascular device
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Nov 1992
Decision
119d
Days
Class 1
Risk

K923327 is an FDA 510(k) clearance for the STETHOSCOPE COVER. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by Anup Chakraborty Co. (Lincoln, US). The FDA issued a Cleared decision on November 3, 1992 after a review of 119 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.

View all Anup Chakraborty Co. devices

Submission Details

510(k) Number K923327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date November 03, 1992
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
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.