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, Pajunk GmbH and B.Braun Medical, Inc..
152
Total
152
Cleared
185d
Avg days
1981
Since
Growing category -
5 submissions in the last 2 years
vs 2 in the prior period
Consistent review times:
160d avg (recent)
FDA 510(k) Cleared Needle, Conduction, Anesthetic (w/wo Introducer) Devices (Product Code BSP)
152 devices
Cleared
Jul 01, 2025
SonoMSK
PAJUNK GmbH Medizintechnologie
Anesthesiology
214d
Cleared
Jun 27, 2025
SonoPlex STIM
PAJUNK GmbH Medizintechnologie
Anesthesiology
210d
Cleared
Jun 25, 2025
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
PAJUNK GmbH Medizintechnologie
Anesthesiology
103d
Cleared
Mar 24, 2025
SonoTAP and SonoTAP II
PAJUNK GmbH Medizintechnologie
Anesthesiology
130d
Cleared
Nov 22, 2024
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
PAJUNK GmbH Medizintechnologie
Anesthesiology
142d
Cleared
Sep 11, 2024
SonoBlock
PAJUNK GmbH Medizintechnologie
Anesthesiology
70d
Cleared
Mar 21, 2024
Reach Needle
Aerin Medical, Inc.
Anesthesiology
51d
Cleared
Jul 29, 2022
Medispine - Spinal Needle, Glospine - Spinal Needle
Global Medikit Limited
Anesthesiology
315d
Cleared
Jul 01, 2022
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
Becton, Dickinson and Company
Anesthesiology
445d
Cleared
Dec 22, 2021
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
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
Myco Medical Supplies, Inc.
Anesthesiology
287d
Cleared
Sep 26, 2021
DiscCath Needle Set
Disccath, LLC
Anesthesiology
61d
Cleared
Sep 29, 2020
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
Becton, Dickinson and Company
Anesthesiology
322d
Cleared
May 27, 2020
Stimuplex Onvision System
Philips Medical Systems Nederland B.V.
Anesthesiology
225d
Cleared
Feb 06, 2020
Ancora Nerve Block Catheter Set
Ancora Medical Technology
Anesthesiology
269d
Cleared
Aug 21, 2019
Arrow Epidural Needle KZ-05500-007(Luer)
Teleflex Medical
Anesthesiology
226d
Cleared
Aug 12, 2019
Dr J Spinal and Epidural Needles
Dr. Japan Co., Ltd.
Anesthesiology
255d
Cleared
Jun 12, 2018
Portex NRFit Epidural Needles
Smiths Medical Asd, Inc.
Anesthesiology
267d
Cleared
Jun 07, 2018
Pakter Curved Needle Set
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
Smiths Medical Asd, Inc.
Anesthesiology
296d
Cleared
May 18, 2018
GRAFTSITE
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
Teleflex Medical
Anesthesiology
187d
Cleared
Feb 02, 2018
IMD's Lumbar Puncture Needle
International Medical Development, Inc.(Imd)
Anesthesiology
386d
Cleared
Jan 25, 2018
EchoGlo Needle
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 - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - BSP Product Code
FDA review times for BSP submissions have been consistent, averaging 160 days recently vs 186 days historically.
BSP devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →