Cleared Special

K121403 - CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET

K121403 is an FDA 510(k) clearance for CONTINUOUS PERIPHERAL NERVE BLOCK CATHE..., manufactured by Teleflex, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Special 510(k) pathway after a 41-day FDA review.

K121403 · Teleflex, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
41d
Days
Class 2
Risk

K121403 is an FDA 510(k) clearance for the CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Teleflex, Inc. (Reading, US). The FDA issued a Cleared decision on June 20, 2012 after a review of 41 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.

FDA 510(k) Submission Details - K121403

510(k) Number K121403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2012
Decision Date June 20, 2012
Days to Decision 41 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
99d faster than avg
Panel avg: 140d · This submission: 41d
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 137
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K121403.
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
K110053 · Smiths Medical Asd, Inc. · Sep 2012
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
K122027 · Arrow International, Inc. · Aug 2012
PERIFUSE CATHETER
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FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER
K103658 · Teleflex, Inc. · May 2012
FENESTRATED NERVE BLOCK NEEDLE
K113662 · Imd, Inc. · Apr 2012
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K113188 · PAJUNK GmbH Medizintechnologie · Mar 2012