Cleared Traditional

K924889 - ZEFON ADULT ANESTHESIA BREATHING CIRCUIT

K924889 is the FDA 510(k) clearance for ZEFON ADULT ANESTHESIA BREATHING CIRCUIT by Zefon Medical Products. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K924889 · Zefon Medical Products · Anesthesiology device
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Mar 1993
Decision
172d
Days
Class 1
Risk

K924889 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 Zefon Medical Products (Ocala, US). The FDA issued a Cleared decision on March 19, 1993 after a review of 172 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 Zefon Medical Products devices

Submission Details

510(k) Number K924889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date March 19, 1993
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 140d · This submission: 172d
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.

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

All 25
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K924889.
PEDIATRIC ANESTHESIA CIRCUITS
K932585 · Merit Medical Systems, Inc. · Jul 1993
CUSTOM ANESTHESIA CIRCUITS
K932586 · Merit Medical Systems, Inc. · Jul 1993
COAXIAL CIRCUITS
K932587 · Merit Medical Systems, Inc. · Jul 1993
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
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
K905450 · Vital Signs, Inc. · Jul 1991