Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HAW — Predicate Candidate Screening
424 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
267 days90th percentile
424clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026-08-05 | 57 | 0 |
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 | 162 | 0 |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026-03-26 | 177 | 0 |
| K231897 | NeuroAlign software | Medivis, Inc. | 2025-10-21 | 846 | 0 |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025-09-05 | 129 | 0 |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025-09-04 | 163 | 0 |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | 2025-07-09 | 138 | 0 |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 | 267 | 0 |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | 2025-02-05 | 271 | 0 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial wi | Brainlab AG | 2025-01-28 | 60 | 0 |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025-01-24 | 58 | 0 |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025-01-17 | 252 | 0 |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024-12-27 | 128 | 0 |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-10-04 | 57 | 0 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 | 161 | 0 |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | 2024-01-12 | 107 | 0 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 | 107 | 0 |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | 2024-01-12 | 107 | 0 |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-01-10 | 30 | 0 |
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023-11-27 | 60 | 0 |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | 2023-10-19 | 108 | 0 |
| K232102 | ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. | 2023-09-15 | 63 | 0 |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq A | Brainlab AG | 2023-09-09 | 260 | 0 |
| K230661 | Zeta Cranial Navigation System | Zeta Surgical | 2023-09-08 | 182 | 0 |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation | Brainlab AG | 2023-07-21 | 269 | 0 |
| K231103 | ROSA ONE Brain Application | Medtech S.A.S | 2023-07-20 | 92 | 0 |
| K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. | 2023-07-14 | 63 | 1 |
| K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023-06-18 | 524 | 0 |
| K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Ster | Brainlab AG | 2023-04-19 | 145 | 0 |
| K223577 | Localite TMS Navigator TS | Localite GmbH | 2023-04-17 | 138 | 0 |
| K221544 | MagVenture TMS Atlas Neuro Navigation System | Tonica Elektronik A/S | 2023-03-17 | 294 | 0 |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2023-02-22 | 28 | 0 |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, Cr | Stryker Corporation | 2023-02-16 | 582 | 1 |
| K222519 | ClearPoint System | ClearPoint Neuro, Inc. | 2022-09-16 | 28 | 0 |
| K213989 | Cranial EM System | Brainlab AG | 2022-09-08 | 262 | 0 |
| K220897 | Disposable Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2022-08-17 | 142 | 0 |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | Medtronic Navigation, Inc. | 2022-06-10 | 58 | 2 |
| K214065 | ROSA ONE Brain application | Medtech S.A.S | 2022-05-04 | 128 | 0 |
| K214040 | ClearPoint Array System (version 1.1) | ClearPoint Neuro, Inc. | 2022-04-12 | 110 | 0 |
| K210109 | visor2 system | Eemagine Medical Imaging Solutions GmbH | 2022-04-08 | 444 | 0 |
| K212397 | StealthStation S8 Cranial v2.0 | Medtronic Navigation | 2021-12-22 | 142 | 1 |
| K201435 | Molecular Flow Simulations | Therataxis, LLC | 2021-12-03 | 550 | 0 |
| K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment | Brainlab AG | 2021-11-12 | 224 | 0 |
| K211544 | Trajectory Planning, Elements Trajectory Planning, Elements | Brainlab AG | 2021-11-03 | 168 | 0 |
| K203251 | SOLOPASS System | Intravent Medical Partners, LP | 2021-08-27 | 296 | 0 |
| K210700 | NaviNetics D1 Stereotactic System | Navinetics, Inc. | 2021-06-17 | 100 | 0 |
| K201752 | Disposable Pre-calibrated Suction | Brainlab AG | 2021-01-29 | 217 | 0 |
| K202575 | ClearPoint Array System | ClearPoint Neuro, Inc. | 2021-01-22 | 140 | 0 |
| K203639 | StealthStation Cranial Software v1.3.2 | Medtronic Navigation, Inc. | 2021-01-13 | 30 | 0 |
| K192703 | Cranial Image Guided Surgery System, Navigation Software Cra | Brainlab AG | 2020-10-08 | 377 | 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