Cleared Traditional

PERIFIX CATHETER CONNECTOR (K032144) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032144 · B.Braun Medical, Inc. · Anesthesiology device
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Oct 2003
Decision
79d
Days
Class 2
Risk

K032144 is an FDA 510(k) clearance for the PERIFIX CATHETER CONNECTOR. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on October 1, 2003 after a review of 79 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K032144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2003
Decision Date October 01, 2003
Days to Decision 79 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
61d faster than avg
Panel avg: 140d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K032144.
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
K090995 · B.Braun Medical, Inc. · Aug 2009
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K063282 · B.Braun Medical, Inc. · Jun 2007
PERIFIX CATHETER CONNECTOR
K033952 · B.Braun Medical, Inc. · Feb 2004
SOFT TIP EPIDURAL CATHETER KIT
K971233 · B.Braun Medical, Inc. · Oct 1997
PERIFIX PEDIATRIC EPIDURAL KIT
K962696 · B.Braun Medical, Inc. · Apr 1997
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
K962880 · Sherwood Medical Co. · Dec 1996