Cleared Traditional

K935168 - ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS

K935168 is an FDA 510(k) clearance for ZEFON PEDIATRIC ANESTHESIA BREATHING CI..., manufactured by Bill Olson Corp.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 103-day FDA review.

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

FDA 510(k) Submission Details - K935168

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
37d faster than avg
Panel avg: 140d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 117
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K935168.
M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K942136 · Mag, Inc. · Jun 1994
ADULT ANESTHESIA BREATHING CIRCUIT
K942568 · Med-Plastics Intl., Inc. · Jun 1994
MAPLESON D CIRCUIT
K942570 · Med-Plastics Intl., Inc. · Jun 1994
THE INFANT FLOW SYSTEM
K930713 · Sechrist Industries, Inc. · Sep 1993
GAS SAMPLING LINES AND CONNECTORS
K932562 · Life Shield Healthcare Products, Inc. · Jul 1993
ADULT ANESTHESIA BREATHING CIRCUIT
K932707 · Precision Med Products, Ltd. · Jul 1993