Atlas FDA

BSP

152 FDA 510(k) clearances · Product code

154 daysmedian time to decision
362 days90th percentile
152clearances measured

FDA profile

Official device name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5150
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 52 · 2022: 84 · 2023: 75 · 2024: 66 · 2025: 87 · 2026: 59
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SonoMSK (K243690)PAJUNK GmbH Medizintechnologie2025-07-01
SonoPlex STIM; SonoPlex II (K243682)PAJUNK GmbH Medizintechnologie2025-06-27
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (K250774)PAJUNK GmbH Medizintechnologie2025-06-25
SonoTAP and SonoTAP II (K243525)PAJUNK GmbH Medizintechnologie2025-03-24
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (K241953)PAJUNK GmbH Medizintechnologie2024-11-22
SonoBlock; SonoBlock II (K241954)PAJUNK GmbH Medizintechnologie2024-09-11
Reach Needle (K240253)Aerin Medical, Inc.2024-03-21
Medispine - Spinal Needle, Glospine - Spinal Needle (K212982)Global Medikit Limited2022-07-29
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (K211085)Becton, Dickinson and Company2022-07-01
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (K210978)Becton, Dickinson and Company2021-12-22
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles (K203668)Myco Medical Supplies, Inc.2021-09-29
DiscCath Needle Set (K212328)Disccath, LLC2021-09-26
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle (K193131)Becton, Dickinson and Company2020-09-29
Stimuplex Onvision System (K192914)Philips Medical Systems Nederland B.V.2020-05-27
Ancora Nerve Block Catheter Set (K191290)Ancora Medical Technology2020-02-06
Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) (K190026)Teleflex Medical2019-08-21
Dr J Spinal and Epidural Needles (K183316)Dr. Japan Co., Ltd.2019-08-12
Portex NRFit Epidural Needles (K172823)Smiths Medical Asd, Inc.2018-06-12
Pakter Curved Needle Set (K173155)Cook Incorporated2018-06-07
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.2018-06-01
GRAFTSITE (K173110)Summit Medical , Ltd.2018-05-18
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 Medical2018-04-25
IMD's Lumbar Puncture Needle (K170112)International Medical Development, Inc.(Imd)2018-02-02
EchoGlo Needle (K171968)Smiths Medical Asd, Inc.2018-01-25
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (K171518)Zhejiang Kindly Medical Devices Co., Ltd.2018-01-05
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford (K163292)Spectra Medical Devices2017-09-08
NerveGuard NRFit, NerveGuard LUER (K170435)PAJUNK GmbH Medizintechnologie2017-07-12
Pinpoint GT Needles (K163216)C.R. Bard, Inc.2017-06-27
Entellus Medical Reinforced Anesthesia Needle (K163435)Entellus Medical, Inc.2017-04-05
Tuohy NRFit (K160297)PAJUNK GmbH Medizintechnologie2016-10-28
SPROTTE SPECIAL NRFit (K160296)PAJUNK GmbH Medizintechnologie2016-10-27
SPROTTE NRFit, Quincke NRFit (K160295)PAJUNK GmbH Medizintechnologie2016-10-27
SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles (K160294)PAJUNK GmbH Medizintechnologie2016-10-21
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle (K151069)Spectra Medical Devices, Inc.2016-02-05
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit (K151072)Solo-Dex, Inc.2016-01-22
Remington Medical Inc. Tuohy Epidural Needles (K150266)Remington Medical, Inc.2015-06-04
UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle (K142553)Unisis Corp.2015-01-14
UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE (K141126)Unisis Corp.2014-10-31
PERICAN ULTRA (K133632)B.Braun Medical, Inc.2014-06-27
ANESTHESIA CONDUCTION NEEDLES (K131006)Lccs Products Limited2013-12-06
SONIXGPS (K121812)Ultrasonix Medical Corporation2013-12-02
ANESTHESIA CONDUCTION NEEDLES (K120475)Shanghai Samedical & Plastic Instruments Co., Ltd.2012-12-21
CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE (K121846)B.Braun Medical, Inc.2012-11-20
SONO TAP, TUOHY SONO (K113207)Pajunk GmbH2012-02-29
PENCAN SPINAL NEEDLE (K112515)B.Braun Medical, Inc.2011-12-22
SONO-SERIES CORNERSTONE TECHNIQUE (K111374)PAJUNK GmbH Medizintechnologie2011-08-29
MEDLINE EPIDURAL AND SPINAL NEEDLES (K110194)Medline Industries, Inc.2011-06-17
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE (K101728)Cook, Inc.2010-08-25
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 (K100241)B.Braun Medical, Inc.2010-04-16
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE (K093209)Cook, Inc.2010-02-26
BD SPINAL NEEDLE 27G (K091758)Becton Dickson & Co.2009-10-09
LAURIMED SPINAL INJECTION SYSTEM (K091818)Laurimed, LLC2009-09-23
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G (K090261)Smiths Medical Asd, Inc.2009-05-01
SPINAL INJECTION SYSTEM (K083909)Laurimed, LLC2009-03-18
STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 (K082772)Life-Tech, Inc.2009-02-09
PROLONG (K081864)Life-Tech, Inc.2008-09-25
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED (K080603)Te ME NA Sas2008-08-05
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 (K081446)Becton, Dickinson & CO2008-07-17
LAURIMED SPINAL INJECTION SYSTEM (K080140)Laurimed, LLC2008-05-09
MODIFICATION TO:SPECIALTY NEEDLES (K073222)Busse Hospital Disposables, Inc.2008-04-09
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR (K073516)Kyphon, Inc.2008-02-21
RK EPIDURAL NEEDLE (K072005)Epimed International2008-02-07
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE (K063350)PAJUNK GmbH Medizintechnologie2008-02-01
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT) (K070354)International Medical Development, Inc.2007-10-05
ECHOSTIM FACET TIP (K063380)Havel'S, Inc.2007-04-25
DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B (K063071)Kyphon, Inc.2007-04-13
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) (K061394)Busse Hospital Disposables, Inc.2006-09-06
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B (K061210)Kyphon, Inc.2006-06-27
RX EPIDURAL NEEDLE (K053318)Epimed International, Inc.2006-02-17
PROBLOC, HN SERIES AND PROLONG, PL SERIES (K050499)Life-Tech, Inc.2005-05-17
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE (K043500)Innospine, Inc.2005-04-15
FLEXIBLE SPINAL NEEDLE (K043467)Epimed International, Inc.2005-03-31
MODIFICATION TO: PLEXALONG SETS (K042979)Pajunk GmbH2004-12-21
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (K040965)Pajunk GmbH2004-09-07
PENCIL POINT NEEDLE (K041843)Epimed International, Inc.2004-08-24
SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 (K032981)Invamed Technologies, Inc.2004-04-22
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE (K030618)Wilson-Cook Medical, Inc.2003-05-27
TUOHY EPIDURAL NEEDLE (K030562)Epimed International, Inc.2003-04-03
MODIFICATION TO PLEXOLONG SETS (K023218)Pajunk GmbH2003-03-24
DR. JAPAN FACIL POINT SPINAL NEEDLE (K020934)Myco Medical, Inc.2002-10-25
QUINCKE SPINAL NEEDLE (K022029)Epimed International, Inc.2002-07-30
LUTZ NEEDLE (K013892)Ballard Medical Products2002-07-11
PERIFIX SAFETY EPIDURAL NEEDLES (K013610)B.Braun Medical, Inc.2002-01-25
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L (K013231)Avid N.I.T., Inc.2001-12-03
BALLPEN SPINAL NEEDLE W/WO INTRODUCER (K011122)Rusch Intl.2001-11-16
MANAN SPRITACRE SPINAL NEEDLES (K011209)Manan Medical Products, Inc.2001-06-26
SPINAL EPIDURAL NEEDLES (K002405)Te ME NA S.A.R.L.2001-06-01
PHOENIX EPIDURAL & SPINAL NEEDLES (K990519)Myco Medical Supplies, Inc.2000-06-02
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK (K993619)Sims Portex, Inc.2000-04-28
UNIPOLAR NEEDLES (K000722)Pajunk GmbH2000-03-31
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (K000495)Ballard Medical Products2000-03-28
MANAN SPINAL NEEDLES (K983620)Manan Medical Products, Inc.1999-01-08
EPIDURAL NEEDLE (K980536)Manan Medical Products, Inc.1998-07-31
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER (K972595)Avid N.I.T., Inc.1998-05-20
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) (K951928)Csen , Ltd.1997-05-30
TUOHY EPIDURAL NEEDLES (K961152)Hakko Shoji Co., Ltd.1997-03-19
SPINAL NEEDLES (K961151)Hakko Shoji Co., Ltd.1997-03-19
ANESTHESIA CONDUCTION NEEDLE (K962886)Ispg, Inc.1996-10-09
GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) (K961444)Global Medical Products, Ltd.1996-08-01
POLYMEDIC SPINAL NEEDLE AND INTRODUCER (K940061)Techniques Medicales DE Navaree1995-12-21
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Every clearance here is in the API, with alerts when new ones post.