Cleared Traditional

K932305 - VILA-COOKE(TM) ANESTHESIA PILLOW

K932305 is an FDA 510(k) clearance for VILA-COOKE(TM) ANESTHESIA PILLOW, manufactured by Sharn, Inc.. The device is a Class 1 Anesthesiology device with product code CCX cleared through the Traditional 510(k) pathway after a 146-day FDA review.

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

FDA 510(k) Submission Details - K932305

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
6d slower than avg
Panel avg: 140d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

CCX Device Classification - Class 1, General Controls

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.