Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GWF — Predicate Candidate Screening
140 FDA 510(k) clearances under this product code; the 50 most recent screened below.
139 daysmedian FDA review time
271 days90th percentile
140clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | 2026-06-27 | 271 | 0 |
| K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | 2026-01-11 | 125 | 1 |
| K243982 | Nicolet EDX | Natus Neurology Incorporated | 2025-01-22 | 30 | 0 |
| K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | 2024-12-12 | 30 | 0 |
| K242345 | Delphi Stimulator | Quantalx Neuroscience | 2024-11-05 | 90 | 0 |
| K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024-04-19 | 115 | 0 |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 1 | Soterix Medical, Inc. | 2024-03-25 | 94 | 0 |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS | Inomed Medizintechnik GmbH | 2023-10-27 | 28 | 0 |
| K230415 | Cadwell Guardian | Cadwell Industries, Inc. | 2023-08-17 | 182 | 0 |
| K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022-03-09 | 89 | 0 |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS | Inomed Medizintechnik GmbH | 2022-01-07 | 179 | 0 |
| K192823 | MEGA-TMS | Soterix Medical, Inc. | 2021-08-13 | 681 | 0 |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft , Ltd. | 2021-05-22 | 796 | 0 |
| K200759 | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | 2020-10-28 | 218 | 4 |
| K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019-02-22 | 158 | 0 |
| K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView Softwa | Neurovision Medical Product, Inc. | 2017-04-05 | 30 | 0 |
| K162873 | MEP Monitor | Tonica Elektronik A/S | 2017-03-31 | 169 | 0 |
| K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017-03-02 | 209 | 2 |
| K160280 | MagPro R20 | Tonica Elektronik A/S | 2016-05-16 | 104 | 0 |
| K150220 | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 U | Eb Neuro S.P.A. | 2015-08-19 | 201 | 0 |
| K142624 | Neuromaster G1 MEE200 | Nihon Kohden Corporation | 2015-04-24 | 220 | 0 |
| K132616 | EPAD | Safeop Surgical, Inc. | 2014-01-24 | 156 | 0 |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | The Magstim Company , Ltd. | 2013-08-23 | 185 | 0 |
| K123843 | NEUROEPG SYSTEM | Strohl Medical Technologies | 2013-06-05 | 174 | 0 |
| K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | Natus Neurology Incorporated | 2013-05-02 | 80 | 0 |
| K120397 | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTE | Nihon Kohden Corp. | 2012-09-19 | 224 | 0 |
| K112881 | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM | Nexstim OY | 2012-05-22 | 235 | 1 |
| K120979 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012-04-25 | 23 | 0 |
| K112052 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012-03-15 | 241 | 0 |
| K111647 | C2 NERVEMONITOR SYSTEM WITH ACCESSORIES | Inomed Medizintechnik GmbH | 2011-10-06 | 115 | 0 |
| K110140 | NEUROVISION NERVE LOCATOR MONITOR | Neurovision Medical Products, Inc. | 2011-09-30 | 255 | 0 |
| K093304 | PROTEKTOR 32 | Natus Medical, Inc. | 2010-08-11 | 294 | 1 |
| K094054 | MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE | Nuvasive, Inc. | 2010-05-14 | 134 | 0 |
| K091940 | MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION | Tonica Elektronik A/S | 2010-03-26 | 269 | 0 |
| K083371 | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) | Natus Medical, Inc. | 2009-12-08 | 389 | 0 |
| K091457 | NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM | Nexstim OY | 2009-12-08 | 204 | 1 |
| K090298 | NUVASIVE NEURO VISION SYSTEM | Nuvasive, Inc. | 2009-06-08 | 122 | 0 |
| K082614 | EVOX ELECTRO DIAGNOSTIC DEVICE | Laborie Medical Technologies, Inc. | 2009-03-06 | 178 | 0 |
| K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009-02-27 | 128 | 3 |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | The Magstim Company , Ltd. | 2008-12-08 | 287 | 0 |
| K071969 | SEN-4100 ELECTRIC STIMULATOR | Nihon Kohden America, Inc. | 2008-10-06 | 447 | 0 |
| K072343 | NEUROVISION JJB SYSTEM | Nuvasive, Inc. | 2007-10-29 | 69 | 0 |
| K071821 | COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 | Tonica Elektronik A/S | 2007-07-27 | 24 | 0 |
| K062765 | MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | 2007-01-24 | 117 | 0 |
| K061639 | ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL | Axon Systems, Inc. | 2006-11-01 | 142 | 0 |
| K061645 | MAGPRO, MODEL R30 | Tonica Elektronik A/S | 2006-10-31 | 141 | 0 |
| K060847 | MAGSTIM 200-2 | Magstim Company Us, LLC | 2006-09-26 | 182 | 0 |
| K061113 | ORTHOMON | Axon Systems, Inc. | 2006-05-23 | 32 | 0 |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005- | The Magstim Company , Ltd. | 2005-12-21 | 166 | 0 |
| K051357 | DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; D | Digitimer , Ltd. | 2005-09-20 | 119 | 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