Cleared Traditional

K935168 - ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K935168 · Bill Olson Corp. · Anesthesiology device
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Feb 1994
Decision
103d
Days
Class 1
Risk

K935168 is an FDA 510(k) clearance for the ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Bill Olson Corp. (Ocala, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Bill Olson Corp. devices

Submission Details

510(k) Number K935168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 27, 1993
Decision Date February 07, 1994
Days to Decision 103 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
36d faster than avg
Panel avg: 139d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.