Cleared Traditional

K193131 - BD Quincke Spinal NRFit Needle

K193131 is an FDA 510(k) clearance for BD Quincke Spinal NRFit Needle, manufactured by Becton, Dickinson and Company. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K193131 · Becton, Dickinson and Company · Anesthesiology device
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Sep 2020
Decision
322d
Days
Class 2
Risk

K193131 is an FDA 510(k) clearance for the BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal In.... Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on September 29, 2020 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K193131

510(k) Number K193131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2019
Decision Date September 29, 2020
Days to Decision 322 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
182d slower than avg
Panel avg: 140d · This submission: 322d
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 K193131.
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K210978 · Becton, Dickinson and Company · Dec 2021
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
K203668 · Myco Medical Supplies, Inc. · Sep 2021
DiscCath Needle Set
K212328 · Disccath, LLC · Sep 2021
Stimuplex Onvision System
K192914 · Philips Medical Systems Nederland B.V. · May 2020
Ancora Nerve Block Catheter Set
K191290 · Ancora Medical Technology · Feb 2020
Arrow Epidural Needle KZ-05500-007(Luer)
K190026 · Teleflex Medical · Aug 2019