Cleared Traditional

K190026 - Arrow Epidural Needle KZ-05500-007(Luer)

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

K190026 is an FDA 510(k) clearance for Arrow Epidural Needle KZ-05500-007(Luer), manufactured by Teleflex Medical. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 226-day FDA review.

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

FDA 510(k) Submission Details - K190026

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.

BSP Device Classification - Class 2, Special Controls

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 72
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