Cleared Traditional

K172823 - Portex NRFit Epidural Needles

K172823 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 267-day FDA review.

K172823 · Smiths Medical Asd, Inc. · Anesthesiology device
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Jun 2018
Decision
267d
Days
Class 2
Risk

K172823 is an FDA 510(k) clearance for the Portex NRFit Epidural Needles. 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 12, 2018 after a review of 267 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 - K172823

510(k) Number K172823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date June 12, 2018
Days to Decision 267 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
127d slower than avg
Panel avg: 140d · This submission: 267d
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 104
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K172823.
Ancora Nerve Block Catheter Set
K191290 · Ancora Medical Technology · Feb 2020
Arrow Epidural Needle KZ-05500-007(Luer)
K190026 · Teleflex Medical · Aug 2019
Dr J Spinal and Epidural Needles
K183316 · Dr. Japan Co., Ltd. · Aug 2019
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K173155 · Cook Incorporated · Jun 2018
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 · Smiths Medical Asd, Inc. · Jun 2018
GRAFTSITE
K173110 · Summit Medical , Ltd. · May 2018