Cleared Traditional

K052946 - MPS ACACIA NERVE BLOCK NEEDLE

K052946 is an FDA 510(k) clearance for MPS ACACIA NERVE BLOCK NEEDLE, manufactured by Mps Acacia. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K052946 · Mps Acacia · Anesthesiology device
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Dec 2005
Decision
49d
Days
Class 2
Risk

K052946 is an FDA 510(k) clearance for the MPS ACACIA NERVE BLOCK NEEDLE. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Mps Acacia (Brea, US). The FDA issued a Cleared decision on December 8, 2005 after a review of 49 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 Mps Acacia devices

FDA 510(k) Submission Details - K052946

510(k) Number K052946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2005
Decision Date December 08, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
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 99
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K052946.
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K043130 · Pajunk GmbH · Dec 2004
STIMULONG PLUS CATHETER SET MODEL, VARIOUS
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PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
K033080 · Portex, Inc. · Mar 2004