Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FGB — Predicate Candidate Screening
115 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
265 days90th percentile
115clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253505 | Zamenix™ P | Roen Surgical, Inc. | 2026-08-07 | 280 | 0 |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C | MacroLux Medical Technology Co., Ltd. | 2026-07-20 | 153 | 0 |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope | Anhui Happiness Workshop Instruments Co., Ltd. | 2026-04-09 | 206 | 0 |
| K260013 | CVAC Image Processor | Calyxo, Inc. | 2026-03-06 | 60 | 0 |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single- | Zhejiang Geyi Medical Instrument Co., Ltd. | 2025-12-16 | 132 | 0 |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-12-16 | 174 | 0 |
| K253411 | Miniature Telescope for Urology (27033AA) | Karl Storz SE & CO. KG | 2025-11-18 | 49 | 0 |
| K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image | Shenzhen Sanping Image Technology Co., Ltd. | 2025-10-31 | 218 | 0 |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-10-03 | 30 | 0 |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - St | Boston Scientific Corporation | 2025-09-24 | 28 | 0 |
| K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Med | Seplou (Zhuhai) Co., Ltd. | 2025-08-26 | 228 | 0 |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & CO. KG | 2025-06-06 | 203 | 0 |
| K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-U | Opcom Medical, Inc. | 2025-05-28 | 261 | 0 |
| K250785 | Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2025-05-06 | 53 | 0 |
| K243894 | F88 URE-SD/RD Flexible Ureteroscope | Sg Endoscopy Pte, Ltd. | 2025-05-02 | 135 | 0 |
| K243532 | LumiRex Ureteroscope | Contra Healthcare Solutions, LLC | 2025-04-28 | 164 | 0 |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-04-11 | 116 | 0 |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: | Scivita Medical Technology Co., Ltd. | 2025-03-27 | 115 | 0 |
| K243155 | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, | Dongguan Zsr Biomedical Technology Company Limited | 2025-02-11 | 134 | 0 |
| K243117 | Digital Video Processor | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-29 | 121 | 0 |
| K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, | Hunan Endoso Life Technology Co., Ltd. | 2025-01-22 | 203 | 0 |
| K241434 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-04 | 136 | 0 |
| K240074 | Single use flexible ureteroscope (UR-D1); Single use flexibl | Shenzhen Besdata Technology Co., Ltd. | 2024-10-04 | 268 | 0 |
| K240203 | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); | Dyne Medical Group, Inc. | 2024-09-05 | 224 | 0 |
| K242108 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ | Ambu A/S | 2024-08-16 | 29 | 0 |
| K233700 | Avicenna Roboflex | Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi | 2024-08-16 | 273 | 0 |
| K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL ST | Karl Storz SE & CO. KG | 2024-08-01 | 29 | 0 |
| K233372 | KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & CO. KG | 2024-07-25 | 297 | 14 |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Sin | Zhuhai Pusen Medical Technology Co., Ltd. | 2024-07-16 | 232 | 0 |
| K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - St | Boston Scientific Corporation | 2024-07-01 | 27 | 0 |
| K241639 | Single-use Video Ureterorenoscope (SVU-220US) | Huger Medical Instrument Co., Ltd. | 2024-07-01 | 24 | 0 |
| K233630 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ | Ambu A/S | 2024-06-24 | 224 | 0 |
| K232911 | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positi | Karl Storz Endovision, Inc. | 2024-06-10 | 265 | 0 |
| K240374 | Ureterorenoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-05-10 | 93 | 0 |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) | Gyrus Acmi, Inc. | 2024-03-25 | 178 | 0 |
| K231135 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2024-01-17 | 271 | 0 |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); C | MacroLux Medical Technology Co., Ltd. | 2024-01-11 | 209 | 0 |
| K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflecti | Boston Scientific Corporation - | 2023-12-12 | 28 | 0 |
| K230475 | Medical Video Endoscope System | Huger Medical Instrument Co., Ltd. | 2023-11-03 | 254 | 0 |
| K223097 | RenaNav Ureteroscope System | CenterPoint Systems, LLC | 2023-07-31 | 304 | 0 |
| K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard | STERIS Corporation | 2023-07-25 | 29 | 0 |
| K230200 | Single-Use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-18 | 113 | 0 |
| K221158 | Single-Use Video Flexible Ureterorenoscope System | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2023-03-06 | 319 | 0 |
| K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard | STERIS Corporation | 2023-02-17 | 92 | 0 |
| K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digita | Boston Scientific Corporation | 2023-02-02 | 253 | 0 |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-10-05 | 26 | 0 |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ure | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-08-26 | 219 | 0 |
| K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022-04-29 | 205 | 1 |
| K211686 | Flexible Video-Choledo-Cysto-Ureteroscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2022-02-22 | 265 | 0 |
| K212458 | Flexible Video-Uretero-Renoscope SSU System | Karl Storz Endoscopy America | 2022-01-20 | 168 | 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