Cleared Traditional

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters (K172410) - FDA 510(k) Clearance

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

K172410 · Smiths Medical Asd, Inc. · Anesthesiology device
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Jun 2018
Decision
296d
Days
Class 2
Risk

K172410 is an FDA 510(k) clearance for the Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss.... Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 1, 2018 after a review of 296 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 Smiths Medical Asd, Inc. devices

Submission Details

510(k) Number K172410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2017
Decision Date June 01, 2018
Days to Decision 296 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
156d slower than avg
Panel avg: 140d · This submission: 296d
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 K172410.
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
GRAFTSITE
K173110 · Summit Medical , Ltd. · May 2018
StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
K173321 · Teleflex Medical · Apr 2018
IMD's Lumbar Puncture Needle
K170112 · International Medical Development, Inc.(Imd) · Feb 2018