Cleared Traditional

K932147 - NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K932147 · Hans Rudolph, Inc. · Anesthesiology device
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Aug 1993
Decision
108d
Days
Class 1
Risk

K932147 is an FDA 510(k) clearance for the NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on August 20, 1993 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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 Hans Rudolph, Inc. devices

Submission Details

510(k) Number K932147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date August 20, 1993
Days to Decision 108 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 139d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
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.