Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BSP — Predicate Candidate Screening
152 FDA 510(k) clearances under this product code; the 50 most recent screened below.
154 daysmedian FDA review time
362 days90th percentile
152clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243690 | SonoMSK | PAJUNK GmbH Medizintechnologie | 2025-07-01 | 214 | 0 |
| K243682 | SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie | 2025-06-27 | 210 | 0 |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | PAJUNK GmbH Medizintechnologie | 2025-06-25 | 103 | 0 |
| K243525 | SonoTAP and SonoTAP II | PAJUNK GmbH Medizintechnologie | 2025-03-24 | 130 | 0 |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | PAJUNK GmbH Medizintechnologie | 2024-11-22 | 142 | 0 |
| K241954 | SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie | 2024-09-11 | 70 | 0 |
| K240253 | Reach Needle | Aerin Medical, Inc. | 2024-03-21 | 51 | 0 |
| K212982 | Medispine - Spinal Needle, Glospine - Spinal Needle | Global Medikit Limited | 2022-07-29 | 315 | 0 |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidura | Becton, Dickinson and Company | 2022-07-01 | 445 | 0 |
| K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spin | Becton, Dickinson and Company | 2021-12-22 | 265 | 0 |
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, | Myco Medical Supplies, Inc. | 2021-09-29 | 287 | 0 |
| K212328 | DiscCath Needle Set | Disccath, LLC | 2021-09-26 | 61 | 0 |
| K193131 | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Nee | Becton, Dickinson and Company | 2020-09-29 | 322 | 0 |
| K192914 | Stimuplex Onvision System | Philips Medical Systems Nederland B.V. | 2020-05-27 | 225 | 0 |
| K191290 | Ancora Nerve Block Catheter Set | Ancora Medical Technology | 2020-02-06 | 269 | 0 |
| K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFi | Teleflex Medical | 2019-08-21 | 226 | 0 |
| K183316 | Dr J Spinal and Epidural Needles | Dr. Japan Co., Ltd. | 2019-08-12 | 255 | 0 |
| K172823 | Portex NRFit Epidural Needles | Smiths Medical Asd, Inc. | 2018-06-12 | 267 | 0 |
| K173155 | Pakter Curved Needle Set | Cook Incorporated | 2018-06-07 | 251 | 0 |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, | Smiths Medical Asd, Inc. | 2018-06-01 | 296 | 0 |
| K173110 | GRAFTSITE | Summit Medical , Ltd. | 2018-05-18 | 231 | 0 |
| K173321 | StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, St | Teleflex Medical | 2018-04-25 | 187 | 0 |
| K170112 | IMD's Lumbar Puncture Needle | International Medical Development, Inc.(Imd) | 2018-02-02 | 386 | 0 |
| K171968 | EchoGlo Needle | Smiths Medical Asd, Inc. | 2018-01-25 | 209 | 0 |
| K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Comb | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-01-05 | 226 | 0 |
| K163292 | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, S | Spectra Medical Devices | 2017-09-08 | 290 | 0 |
| K170435 | NerveGuard NRFit, NerveGuard LUER | PAJUNK GmbH Medizintechnologie | 2017-07-12 | 149 | 0 |
| K163216 | Pinpoint GT Needles | C.R. Bard, Inc. | 2017-06-27 | 223 | 0 |
| K163435 | Entellus Medical Reinforced Anesthesia Needle | Entellus Medical, Inc. | 2017-04-05 | 119 | 0 |
| K160297 | Tuohy NRFit | PAJUNK GmbH Medizintechnologie | 2016-10-28 | 268 | 0 |
| K160296 | SPROTTE SPECIAL NRFit | PAJUNK GmbH Medizintechnologie | 2016-10-27 | 267 | 0 |
| K160295 | SPROTTE NRFit, Quincke NRFit | PAJUNK GmbH Medizintechnologie | 2016-10-27 | 267 | 0 |
| K160294 | SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles | PAJUNK GmbH Medizintechnologie | 2016-10-21 | 261 | 0 |
| K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthes | Spectra Medical Devices, Inc. | 2016-02-05 | 290 | 0 |
| K151072 | Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter | Solo-Dex, Inc. | 2016-01-22 | 276 | 0 |
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | Remington Medical, Inc. | 2015-06-04 | 120 | 0 |
| K142553 | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Dispo | Unisis Corp. | 2015-01-14 | 126 | 0 |
| K141126 | UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE | Unisis Corp. | 2014-10-31 | 183 | 0 |
| K133632 | PERICAN ULTRA | B.Braun Medical, Inc. | 2014-06-27 | 213 | 0 |
| K131006 | ANESTHESIA CONDUCTION NEEDLES | Lccs Products Limited | 2013-12-06 | 239 | 0 |
| K121812 | SONIXGPS | Ultrasonix Medical Corporation | 2013-12-02 | 530 | 0 |
| K120475 | ANESTHESIA CONDUCTION NEEDLES | Shanghai Samedical & Plastic Instruments Co., Ltd. | 2012-12-21 | 309 | 0 |
| K121846 | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE | B.Braun Medical, Inc. | 2012-11-20 | 148 | 0 |
| K113207 | SONO TAP, TUOHY SONO | Pajunk GmbH | 2012-02-29 | 121 | 0 |
| K112515 | PENCAN SPINAL NEEDLE | B.Braun Medical, Inc. | 2011-12-22 | 114 | 0 |
| K111374 | SONO-SERIES CORNERSTONE TECHNIQUE | PAJUNK GmbH Medizintechnologie | 2011-08-29 | 105 | 0 |
| K110194 | MEDLINE EPIDURAL AND SPINAL NEEDLES | Medline Industries, Inc. | 2011-06-17 | 144 | 0 |
| K101728 | FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE | Cook, Inc. | 2010-08-25 | 65 | 0 |
| K100241 | CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686 | B.Braun Medical, Inc. | 2010-04-16 | 79 | 0 |
| K093209 | FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE | Cook, Inc. | 2010-02-26 | 136 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda