Cleared Traditional

K911880 - ZEFON ADULT ANESTHESIA BREATHING CIRCUIT (FDA 510(k) Clearance)

Class I Anesthesiology device.

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

Submission Details

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
96d slower than avg
Panel avg: 139d · This submission: 235d
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.