Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HIH — Predicate Candidate Screening
171 FDA 510(k) clearances under this product code; the 50 most recent screened below.
125 daysmedian FDA review time
332 days90th percentile
171clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | 2026-06-04 | 258 | 0 |
| K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | 2026-05-15 | 149 | 0 |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | 2026-02-26 | 59 | 0 |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2025-12-18 | 111 | 0 |
| K252012 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2025-07-18 | 21 | 0 |
| K243382 | RZ Resectoscope System | Rz Medizintechnik GmbH | 2025-06-03 | 215 | 0 |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, H | MacroLux Medical Technology Co., Ltd. | 2024-08-16 | 128 | 0 |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-08-02 | 25 | 0 |
| K240401 | ClearVision Single Use Hysteroscope & Image Processing Syste | Origyn Medical Technology (Hangzhou) Co., Ltd. | 2024-07-26 | 168 | 0 |
| K231260 | HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology Co., Ltd. | 2024-03-05 | 309 | 0 |
| K233635 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2024-02-12 | 91 | 0 |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysterosc | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-12 | 221 | 0 |
| K233500 | Benesta Tissue Removal Device | Caldera Medical, Inc. | 2023-11-30 | 30 | 0 |
| K223885 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2023-09-14 | 261 | 0 |
| K223813 | Aveta System 2.0 | Meditrina, Inc. | 2023-08-21 | 244 | 0 |
| K223520 | UNIDRIVE SIII System | Karl Storz-Endoscopy-America, Inc. | 2023-04-27 | 155 | 0 |
| K221557 | Visera Hysterovideoscope Olympus HYF Type V | Olympus Medical Systems Corporation | 2022-09-02 | 94 | 2 |
| K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Cora | Meditrina, Inc. | 2022-05-26 | 240 | 0 |
| K213207 | Sheath, Stopcock Accessory | Olympus Winter & Ibe GmbH | 2021-12-22 | 84 | 0 |
| K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | 2021-11-23 | 454 | 0 |
| K210270 | Medical Endoscope Image Processing System | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2021-10-01 | 242 | 0 |
| K211227 | HTx Disposable Hysteroscope System | Acuvu, Inc. | 2021-09-15 | 145 | 0 |
| K192811 | BenestaTM Tissue Removal Device | Caldera Medical, Inc. | 2020-10-23 | 389 | 0 |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2020-10-08 | 85 | 0 |
| K201756 | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSu | Stryker Sustainability Solutions | 2020-09-25 | 88 | 0 |
| K192822 | Benesta Hysteroscope | Caldera Medical, Inc. | 2020-09-09 | 344 | 0 |
| K200038 | Endosee System | CooperSurgical, Inc. | 2020-02-05 | 28 | 0 |
| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, | Lina Medical Aps | 2020-01-17 | 81 | 0 |
| K191538 | Resectr Tissue Resection Device | Boston Scientific Corporation | 2020-01-16 | 220 | 0 |
| K192100 | Aveta Disposable Hysteroscope | Meditrina, Inc. | 2019-12-19 | 136 | 0 |
| K190797 | Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH | Reed Medical (Zhejiang) Co., Ltd. | 2019-11-18 | 235 | 0 |
| K192278 | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatabl | Uvision360, Inc. | 2019-11-01 | 71 | 0 |
| K191958 | Aveta System | Meditrina, Inc. | 2019-10-01 | 70 | 0 |
| K191281 | Omni Hysteroscope, Omni Lok cervical seal | Hologic, Inc. | 2019-08-29 | 108 | 0 |
| K190827 | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable S | Uvision360, Inc. | 2019-06-06 | 66 | 0 |
| K191335 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxio | Corinth Medtech, Inc. | 2019-06-06 | 20 | 0 |
| K182975 | MAKO 7 | Boston Scientific Corporation | 2019-05-21 | 208 | 0 |
| K190372 | Aveta System | Meditrina, Inc. | 2019-05-16 | 90 | 0 |
| K190639 | Endosee System | CooperSurgical, Inc. | 2019-05-15 | 63 | 0 |
| K181545 | Hysteroscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2019-05-10 | 332 | 0 |
| K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxio | Corinth Medtech, Inc. | 2019-04-24 | 90 | 0 |
| K183020 | Endosee System | CooperSurgical, Inc. | 2019-01-31 | 91 | 0 |
| K182675 | Polygon Resection Device | Polygon Medical, Inc. | 2019-01-04 | 100 | 0 |
| K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | 2018-12-06 | 132 | 0 |
| K180496 | TruClear Elite Hysteroscope | Covidien | 2018-08-29 | 184 | 0 |
| K181974 | MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. | 2018-08-23 | 30 | 0 |
| K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting | Corinth Medtech, Inc. | 2018-07-25 | 125 | 0 |
| K173070 | HSW Resection Instruments | Henke-Sass, Wolf GmbH | 2018-06-08 | 252 | 0 |
| K173901 | MyoSure MANUAL Tissue Removal Device | Hologic, Inc. | 2018-05-08 | 137 | 0 |
| K180096 | GDT-1000 System | Acuvu, Inc. | 2018-04-16 | 90 | 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