Cleared Traditional

K935146 - DISPOSABLE STETHOSCOPE HEAD COVER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K935146 · Modern Medical Devices, Inc. · Anesthesiology device
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Jul 1994
Decision
256d
Days
Class 1
Risk

K935146 is an FDA 510(k) clearance for the DISPOSABLE STETHOSCOPE HEAD COVER. Classified as Stethoscope Head (product code BZS), Class I - General Controls.

Submitted by Modern Medical Devices, Inc. (Fremont, US). The FDA issued a Cleared decision on July 11, 1994 after a review of 256 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1930 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Modern Medical Devices, Inc. devices

Submission Details

510(k) Number K935146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date July 11, 1994
Days to Decision 256 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 139d · This submission: 256d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZS Stethoscope Head
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1930
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.