Cleared Traditional

K103658 - FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER

K103658 is an FDA 510(k) clearance for FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER, manufactured by Teleflex, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 518-day FDA review.

K103658 · Teleflex, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
518d
Days
Class 2
Risk

K103658 is an FDA 510(k) clearance for the FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER. 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 May 16, 2012 after a review of 518 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5140 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K103658

510(k) Number K103658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2010
Decision Date May 16, 2012
Days to Decision 518 days
Submission Type Traditional
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
378d slower than avg
Panel avg: 140d · This submission: 518d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K103658.
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
K122027 · Arrow International, Inc. · Aug 2012
PERIFUSE CATHETER
K121525 · Smiths Medical Asd, Inc. · Aug 2012
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
K121403 · Teleflex, Inc. · Jun 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
CONTIPLEX FX
K113059 · B.Braun Medical, Inc. · Jan 2012