Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HRX — Predicate Candidate Screening
681 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
272 days90th percentile
681clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC | 2026-05-26 | 266 | 0 |
| K253523 | Freedom DS™ Decompression System | Spinal Simplicity | 2026-04-16 | 154 | 0 |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026-03-12 | 212 | 0 |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Displ | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 | 85 | 0 |
| K250795 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH | 2025-12-05 | 266 | 0 |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025-11-21 | 88 | 0 |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 | 90 | 0 |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the H | Hand Biomechanics Lab, Inc. | 2025-10-15 | 107 | 0 |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025-09-29 | 45 | 0 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025-08-27 | 264 | 0 |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025-07-30 | 387 | 0 |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 2025-05-16 | 176 | 0 |
| K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | 2024-12-11 | 118 | 0 |
| K243020 | MIDASVu | Intravu, Inc. | 2024-12-02 | 66 | 0 |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024-05-06 | 159 | 0 |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | 2024-04-25 | 59 | 0 |
| K233675 | FMS VUE™ Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | 2024-02-26 | 102 | 0 |
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | 2024-02-06 | 132 | 0 |
| K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | 2023-08-16 | 247 | 0 |
| K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | 2023-04-21 | 367 | 0 |
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | 2023-03-09 | 251 | 0 |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2023-02-02 | 85 | 1 |
| K223244 | Pristine Arthroscopic Visualization System | Pristine Surgical | 2022-12-21 | 62 | 0 |
| K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2022-11-14 | 89 | 0 |
| K213978 | TELIGEN System | Medos International SARL | 2022-10-18 | 302 | 0 |
| K212636 | CORUS Spinal System-X | Providence Medical Technology, Inc. | 2021-10-15 | 57 | 0 |
| K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | Trice Medical, Inc. | 2021-09-15 | 33 | 0 |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2021-06-24 | 57 | 0 |
| K203480 | DOUBLEFLO system | Hemodia Sas | 2021-04-05 | 129 | 0 |
| K202027 | Balex bone Expander System | Taeyeon Medical Co., Ltd. | 2021-02-03 | 196 | 0 |
| K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | 2021-01-15 | 386 | 0 |
| K203526 | C Scope Visualization System | Cit Ortho | 2021-01-12 | 41 | 2 |
| K201113 | Resascope RS-01/B | Advanced Medical Systems Group Srl | 2020-12-21 | 238 | 0 |
| K202659 | Stryker Arthroscope | Stryker | 2020-12-01 | 78 | 0 |
| K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | 2020-10-09 | 359 | 0 |
| K200067 | MectaScope System | Medacta International S.A. | 2020-10-01 | 262 | 0 |
| K200763 | Osteo-site Vertebral Balloon | Izi Medical | 2020-08-12 | 141 | 0 |
| K201349 | Smith+Nephew Arthroscopes | Smith & Nephew | 2020-07-20 | 60 | 0 |
| K200729 | HydroCision SpineJet System | Hydrocision, Inc. | 2020-04-16 | 27 | 0 |
| K191596 | Arcadia Balloon Catheter | Merit Medical Systems, Inc. | 2019-10-09 | 114 | 0 |
| K192155 | Smith & Nephew DYONICS 25 Fluid Management System | Smith & Nephew, Inc. | 2019-09-04 | 26 | 0 |
| K191345 | Pegasus System | A.M. Surgical, Inc. | 2019-07-17 | 58 | 0 |
| K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Stryker Corp. | 2019-07-12 | 63 | 0 |
| K191594 | Nuvis Battery Arthroscope | Integrated Endoscopy, Inc. | 2019-07-11 | 24 | 0 |
| K191579 | Voyant System | Viseon, Inc. | 2019-07-11 | 27 | 0 |
| K190804 | HydroCision TenJet Device | Hydrocision, Inc. | 2019-06-05 | 68 | 0 |
| K182287 | MEDINAUT Plus | Imedicom Co., Ltd. | 2019-04-06 | 226 | 0 |
| K190598 | CROSSWAY Spinal Access System | Globus Medical, Inc. | 2019-04-05 | 29 | 0 |
| K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | 2019-03-08 | 32 | 0 |
| K183165 | Pristine Scope | Pristine Surgical | 2019-01-16 | 62 | 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