Cleared Traditional

K122690 - ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE

K122690 is the FDA 510(k) clearance for ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE by Arrow International, Inc.. It is a Class 2 Anesthesiology device (product code CAZ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K122690 · Arrow International, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
108d
Days
Class 2
Risk

K122690 is an FDA 510(k) clearance for the ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on December 21, 2012 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Arrow International, Inc. devices

Submission Details

510(k) Number K122690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date December 21, 2012
Days to Decision 108 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
32d faster than avg
Panel avg: 140d · This submission: 108d
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 66
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K122690.
VPC
K190345 · PAJUNK GmbH Medizintechnologie · May 2019
Arrow Epidural Catheter Kit
K161075 · Teleflexmedical, Inc. · Oct 2016
Arrow Epidural Catheter Kit
K143581 · Teleflexmedical, Inc. · Jun 2015
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
K110053 · Smiths Medical Asd, Inc. · Sep 2012
PERIFUSE CATHETER
K121525 · Smiths Medical Asd, Inc. · Aug 2012
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K113188 · PAJUNK GmbH Medizintechnologie · Mar 2012