Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Neurology — Predicate Candidate Screening
6,099 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
134 daysmedian FDA review time
298 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026-08-05 | 57 | 0 |
| K261854 | xvision Spine system | Augmedics, Ltd. | 2026-07-31 | 58 | 0 |
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigat | Orthalign, Inc. | 2026-07-31 | 29 | 0 |
| K254038 | Motivista (CT-155) | Click Therapeutics, Inc. | 2026-07-30 | 226 | 0 |
| K260566 | SMARTVERTIGO™ Vestibular Assessment System | VertigoDx, Inc. | 2026-07-30 | 161 | 0 |
| K251959 | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | 2026-07-30 | 399 | 0 |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001- | Suite 201, National Innovation Centre | 2026-07-30 | 91 | 0 |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026-07-29 | 107 | 0 |
| K261058 | CraniUS Plate | CraniUS, LLC | 2026-07-29 | 120 | 0 |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-07-24 | 116 | 0 |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026-07-24 | 31 | 0 |
| K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-07-23 | 226 | 0 |
| K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | 2026-07-22 | 110 | 0 |
| K253814 | Raney Clips Kit | Beijing Honghugaoxiang Science and Technology Development CO | 2026-07-21 | 235 | 0 |
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, | Ambu A/S | 2026-07-14 | 144 | 0 |
| K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026-07-10 | 115 | 0 |
| K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | 2026-07-09 | 66 | 0 |
| K261852 | OTS Hip | Ortoma AB | 2026-07-01 | 28 | 0 |
| K261101 | Ceribell Monitor | Ceribell, Inc. | 2026-06-30 | 89 | 0 |
| K253767 | UB ERP System | Universal Brain | 2026-06-30 | 217 | 0 |
| K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | 2026-06-27 | 271 | 0 |
| K253390 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | 2026-06-27 | 270 | 0 |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2026-06-26 | 200 | 0 |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reu | Cadwell Industries, Inc. | 2026-06-26 | 57 | 0 |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | 2026-06-26 | 137 | 0 |
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Sl | Longeviti Neuro Solutions | 2026-06-25 | 113 | 0 |
| K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2026-06-25 | 132 | 0 |
| K261772 | Target Xtra Detachable Coil | Stryker Neurovscular | 2026-06-24 | 26 | 0 |
| K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | 2026-06-24 | 90 | 0 |
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682 | Integra Lifesciences Production Corporation | 2026-06-23 | 89 | 0 |
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | 2026-06-20 | 135 | 0 |
| K261665 | CORUS™ Navigation System-GN | Providence Medical Technology, Inc. | 2026-06-18 | 29 | 0 |
| K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | 2026-06-18 | 267 | 0 |
| K253055 | Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple | Nordic Kinetics AB | 2026-06-17 | 268 | 0 |
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. | 2026-06-16 | 126 | 0 |
| K261265 | Permatage XT Settable Bone Putty | Orthocon, Inc. | 2026-06-15 | 60 | 0 |
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx ( | Neuroelectrics Barcelona S.L.U. | 2026-06-13 | 30 | 0 |
| K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | 2026-06-12 | 266 | 0 |
| K253607 | UNEEG EpiSight System | Uneeg Medical A/S | 2026-06-11 | 205 | 0 |
| K254086 | EyeBOX SNAP | Oculogica, Inc. | 2026-06-05 | 169 | 0 |
| K253602 | Precision S 4K Sinuscope | Stryker Endoscopy | 2026-06-04 | 198 | 0 |
| K260402 | MeRT System | Wave Neuroscience | 2026-06-03 | 117 | 0 |
| K261522 | BioWave BioWraps | Biowave Corporation | 2026-06-03 | 27 | 0 |
| K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2026-06-03 | 133 | 0 |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instr | Life Spine, Inc. | 2026-06-02 | 103 | 0 |
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Sm | Orthalign, Inc. | 2026-06-02 | 211 | 0 |
| K261540 | Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH | 2026-06-02 | 25 | 0 |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | 2026-05-29 | 59 | 0 |
| K260895 | Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. | 2026-05-28 | 71 | 0 |
| K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026-05-28 | 274 | 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