BSP · Class II · 21 CFR 868.5150

FDA Product Code BSP: Needle, Conduction, Anesthetic (w/wo Introducer)

Under FDA product code BSP, anesthetic conduction needles — with or without introducers — are cleared for regional anesthesia and nerve block procedures.

These specialized needles are designed to deposit local anesthetic adjacent to specific nerves or nerve plexuses, producing regional anesthesia for surgery or pain management. They are available in a range of gauges, lengths, and tip configurations optimized for different nerve block techniques.

BSP devices are Class II medical devices, regulated under 21 CFR 868.5150 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include PAJUNK GmbH Medizintechnologie, Smiths Medical Asd, Inc. and Becton, Dickinson and Company.

152
Total
152
Cleared
185d
Avg days
1981
Since
Growing category - 6 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 145d recently vs 187d historically

FDA 510(k) Cleared Needle, Conduction, Anesthetic (w/wo Introducer) Devices (Product Code BSP)

152 devices
1–24 of 152
Cleared Jul 01, 2025
SonoMSK
K243690
PAJUNK GmbH Medizintechnologie
Anesthesiology · 214d
Cleared Jun 27, 2025
SonoPlex STIM
K243682
PAJUNK GmbH Medizintechnologie
Anesthesiology · 210d
Cleared Jun 25, 2025
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
K250774
PAJUNK GmbH Medizintechnologie
Anesthesiology · 103d
Cleared Mar 24, 2025
SonoTAP and SonoTAP II
K243525
PAJUNK GmbH Medizintechnologie
Anesthesiology · 130d
Cleared Nov 22, 2024
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
K241953
PAJUNK GmbH Medizintechnologie
Anesthesiology · 142d
Cleared Sep 11, 2024
SonoBlock
K241954
PAJUNK GmbH Medizintechnologie
Anesthesiology · 70d
Cleared Mar 21, 2024
Reach Needle
K240253
Aerin Medical, Inc.
Anesthesiology · 51d
Cleared Jul 29, 2022
Medispine - Spinal Needle, Glospine - Spinal Needle
K212982
Global Medikit Limited
Anesthesiology · 315d
Cleared Jul 01, 2022
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
K211085
Becton, Dickinson and Company
Anesthesiology · 445d
Cleared Dec 22, 2021
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K210978
Becton, Dickinson and Company
Anesthesiology · 265d
Cleared Sep 29, 2021
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
K203668
Myco Medical Supplies, Inc.
Anesthesiology · 287d
Cleared Sep 26, 2021
DiscCath Needle Set
K212328
Disccath, LLC
Anesthesiology · 61d
Cleared Sep 29, 2020
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
K193131
Becton, Dickinson and Company
Anesthesiology · 322d
Cleared May 27, 2020
Stimuplex Onvision System
K192914
Philips Medical Systems Nederland B.V.
Anesthesiology · 225d
Cleared Feb 06, 2020
Ancora Nerve Block Catheter Set
K191290
Ancora Medical Technology
Anesthesiology · 269d
Cleared Aug 21, 2019
Arrow Epidural Needle KZ-05500-007(Luer)
K190026
Teleflex Medical
Anesthesiology · 226d
Cleared Aug 12, 2019
Dr J Spinal and Epidural Needles
K183316
Dr. Japan Co., Ltd.
Anesthesiology · 255d
Cleared Jun 12, 2018
Portex NRFit Epidural Needles
K172823
Smiths Medical Asd, Inc.
Anesthesiology · 267d
Cleared Jun 07, 2018
Pakter Curved Needle Set
K173155
Cook Incorporated
Anesthesiology · 251d
Cleared Jun 01, 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.
Anesthesiology · 296d
Cleared May 18, 2018
GRAFTSITE
K173110
Summit Medical , Ltd.
Anesthesiology · 231d
Cleared Apr 25, 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
Anesthesiology · 187d
Cleared Feb 02, 2018
IMD's Lumbar Puncture Needle
K170112
International Medical Development, Inc.(Imd)
Anesthesiology · 386d
Cleared Jan 25, 2018
EchoGlo Needle
K171968
Smiths Medical Asd, Inc.
Anesthesiology · 209d

About Product Code BSP - Regulatory Context

510(k) Submission Activity

152 total 510(k) submissions under product code BSP since 1981, with 152 receiving FDA clearance (average review time: 185 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BSP Product Code

Recent submissions under BSP have taken an average of 145 days to reach a decision - down from 187 days historically, suggesting improved FDA processing for this classification.

BSP devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →