Cleared Traditional

K911880 - ZEFON ADULT ANESTHESIA BREATHING CIRCUIT

K911880 is an FDA 510(k) clearance for ZEFON ADULT ANESTHESIA BREATHING CIRCUIT, 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 235-day FDA review.

K911880 · Bill Olson Corp. · Anesthesiology device
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Dec 1991
Decision
235d
Days
Class 1
Risk

K911880 is an FDA 510(k) clearance for the ZEFON ADULT ANESTHESIA BREATHING CIRCUIT. 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 December 20, 1991 after a review of 235 days - an extended review cycle.

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 - K911880

510(k) Number K911880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date December 20, 1991
Days to Decision 235 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
95d slower than avg
Panel avg: 140d · This submission: 235d
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 K911880.
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS
K925231 · Merit Medical Systems, Inc. · Jan 1993
MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT
K925232 · Merit Medical Systems, Inc. · Jan 1993
ANESTHESIA BREATHING CIRCUIT
K915452 · Concord/Portex · Feb 1992
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
K912065 · Intertech Resources, Inc. · Oct 1991
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
K912504 · Intertech Resources, Inc. · Oct 1991
BODAI NEO2 -SAFE AIRWAY PRESSURE CAP
K913753 · B&B Medical Technologies, Inc. · Oct 1991