Cleared Special

K092657 - EPIFUSE CATHETER CONNECTOR

K092657 is an FDA 510(k) clearance for EPIFUSE CATHETER CONNECTOR, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Special 510(k) pathway after a 68-day FDA review.

K092657 · Smiths Medical Asd, Inc. · Anesthesiology device
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Nov 2009
Decision
68d
Days
Class 2
Risk

K092657 is an FDA 510(k) clearance for the EPIFUSE CATHETER CONNECTOR, MODEL: 4909E. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on November 4, 2009 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5140 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K092657

510(k) Number K092657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2009
Decision Date November 04, 2009
Days to Decision 68 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 140d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

CAZ Device Classification - Class 2, Special Controls

Product Code CAZ Anesthesia Conduction Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5140
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAZ Anesthesia Conduction Kit

All 97
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K092657.
PERIFUSE CATHETER
K121525 · Smiths Medical Asd, Inc. · Aug 2012
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CONTIPLEX FX
K113059 · B.Braun Medical, Inc. · Jan 2012
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
K090995 · B.Braun Medical, Inc. · Aug 2009
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
K082183 · PAJUNK GmbH Medizintechnologie · Oct 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
K082164 · PAJUNK GmbH Medizintechnologie · Oct 2008