Cleared Traditional

K172410 - Portex NRFit Epidural Needles

K172410 is an FDA 510(k) clearance for Portex NRFit Epidural Needles, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 296-day FDA review.

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

FDA 510(k) Submission Details - K172410

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.

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 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