Cleared Traditional

K121525 - PERIFUSE CATHETER

K121525 is an FDA 510(k) clearance for PERIFUSE CATHETER, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K121525 · Smiths Medical Asd, Inc. · Anesthesiology device
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Aug 2012
Decision
71d
Days
Class 2
Risk

K121525 is an FDA 510(k) clearance for the PERIFUSE CATHETER. 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 August 2, 2012 after a review of 71 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 Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K121525

510(k) Number K121525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2012
Decision Date August 02, 2012
Days to Decision 71 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
69d faster than avg
Panel avg: 140d · This submission: 71d
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 97
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K121525.
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
K122690 · Arrow International, Inc. · Dec 2012
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
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K113188 · PAJUNK GmbH Medizintechnologie · Mar 2012
CONTIPLEX FX
K113059 · B.Braun Medical, Inc. · Jan 2012
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
K092657 · Smiths Medical Asd, Inc. · Nov 2009