Cleared Traditional

K932305 - VILA-COOKE(TM) ANESTHESIA PILLOW (FDA 510(k) Clearance)

Class I Anesthesiology device.

K932305 · Sharn, Inc. · Anesthesiology device
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Oct 1993
Decision
146d
Days
Class 1
Risk

K932305 is an FDA 510(k) clearance for the VILA-COOKE(TM) ANESTHESIA PILLOW. Classified as Support, Patient Position (product code CCX), Class I - General Controls.

Submitted by Sharn, Inc. (Tampa, US). The FDA issued a Cleared decision on October 5, 1993 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6820 - 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 Sharn, Inc. devices

Submission Details

510(k) Number K932305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1993
Decision Date October 05, 1993
Days to Decision 146 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
7d slower than avg
Panel avg: 139d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCX Support, Patient Position
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6820
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.