Cleared Traditional

Arrow Epidural Needle KZ-05500-007(Luer) (K190026) - FDA 510(k) Clearance

Also marketed or referenced as:
KZ-05500-009 (NRFit)

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

K190026 · Teleflex Medical · Anesthesiology device
Download Printable Device Report (PDF)
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Aug 2019
Decision
226d
Days
Class 2
Risk

K190026 is an FDA 510(k) clearance for the Arrow Epidural Needle KZ-05500-007(Luer). Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 21, 2019 after a review of 226 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - 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 Teleflex Medical devices

Submission Details

510(k) Number K190026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2019
Decision Date August 21, 2019
Days to Decision 226 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
86d slower than avg
Panel avg: 140d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 43
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K190026.
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
K193131 · Becton, Dickinson and Company · Sep 2020
Stimuplex Onvision System
K192914 · Philips Medical Systems Nederland B.V. · May 2020
Ancora Nerve Block Catheter Set
K191290 · Ancora Medical Technology · Feb 2020
Dr J Spinal and Epidural Needles
K183316 · Dr. Japan Co., Ltd. · Aug 2019
Portex NRFit Epidural Needles
K172823 · Smiths Medical Asd, Inc. · Jun 2018
Pakter Curved Needle Set
K173155 · Cook Incorporated · Jun 2018