Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FAJ — Predicate Candidate Screening
92 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
252 days90th percentile
92clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2 | Olympus Winter & Ibe GmbH | 2026-05-21 | 83 | 0 |
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cy | Verathon Medical (Canada) Ulc | 2026-05-11 | 171 | 0 |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AS | Strauss Surgical USA | 2026-04-16 | 133 | 0 |
| K253905 | PrimeSight UltraView System | Cogentix Medical, Inc. | 2026-04-07 | 123 | 0 |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories In | American Medical Endoscopy, Inc. | 2026-03-27 | 58 | 0 |
| K253226 | UV5000W Handle | Uroviu Corporation | 2025-10-23 | 24 | 0 |
| K251140 | Zenflow Spring Scope | Zenflow, Inc. | 2025-09-23 | 162 | 0 |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY5 | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-09-15 | 28 | 0 |
| K250797 | UV5000 Handle | Uroviu Corporation | 2025-09-11 | 181 | 0 |
| K243653 | KARL STORZ HOPKINS Telescopes for Urology | Karl Storz SE & CO. KG | 2025-08-13 | 260 | 0 |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-08-08 | 28 | 0 |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AS | American Medical Endoscopy, Inc. | 2025-08-01 | 64 | 0 |
| K250269 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope | Ambu A/S | 2025-06-11 | 132 | 0 |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F0 | Hunan Vathin Medical Instrument Co., Ltd. | 2024-12-18 | 114 | 0 |
| K243196 | Uro-G HD Cystoscope (1520) | Uroviu Corporation | 2024-12-13 | 73 | 0 |
| K240849 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope | Ambu A/S | 2024-10-16 | 203 | 0 |
| K240848 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope | Ambu A/S | 2024-10-10 | 197 | 0 |
| K240227 | LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP- | Lina Medical Aps | 2024-08-22 | 209 | 0 |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Us | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-07-12 | 45 | 0 |
| K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-06-21 | 105 | 0 |
| K240283 | BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C | MacroLux Medical Technology Co., Ltd. | 2024-06-10 | 130 | 0 |
| K232837 | Uro-G HD Flexible Cystoscope | Uroviu Corporation | 2024-06-07 | 267 | 0 |
| K231118 | Cystoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-11-13 | 207 | 0 |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, an | Medimaging Integrated Solution, Inc (Miis) | 2023-10-06 | 280 | 0 |
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digi | OTU Medical, Inc. | 2023-09-29 | 109 | 0 |
| K223040 | Endo SmartCap | Medivators, Inc. | 2023-03-01 | 153 | 0 |
| K221683 | CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEO | Olympus Medical Systems Corporation | 2023-01-20 | 224 | 5 |
| K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO | Olympus Medical Systems Corp. | 2022-12-29 | 202 | 3 |
| K221580 | Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 | 170 | 0 |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24 | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-11-09 | 111 | 0 |
| K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Us | Zhuhai Pusen Medical Technology Co., Ltd. | 2022-09-26 | 28 | 0 |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digita | OTU Medical, Inc. | 2022-04-13 | 273 | 0 |
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | Karl Storz Endoscopy America, Inc. | 2021-09-03 | 28 | 0 |
| K210512 | LUMINELLE DTx System | Uvision360, Inc. | 2021-06-30 | 127 | 0 |
| K202921 | Uro-G Cystoscope | Uroviu Corporation | 2021-05-04 | 217 | 0 |
| K202957 | Flexible Video Cysto-Urethroscope (C-view) | KARL STORZ Endoscopy-America, Inc. | 2020-10-29 | 29 | 0 |
| K193095 | Ambu aScope 4 Cysto | Ambu A/S | 2020-04-02 | 147 | 0 |
| K191357 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019-09-18 | 120 | 0 |
| K182876 | Uro-N Cystoscope | Uroviu Corporation | 2019-07-02 | 263 | 0 |
| K182723 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019-04-23 | 207 | 0 |
| K181909 | Luminelle DTx Hysteroscopy System | Uvision360, Inc. | 2018-08-16 | 30 | 0 |
| K171500 | Uro-V Cystoscope | Uroviu Corporation | 2018-01-30 | 252 | 0 |
| K170862 | Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope | Solace Therapeutics, Inc. | 2017-12-19 | 271 | 0 |
| K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0m | Henke-Sass, Wolf GmbH | 2017-12-07 | 213 | 0 |
| K160766 | Ambu USR, Ambu M | Ambu A/S | 2016-08-17 | 149 | 0 |
| K142194 | CytoSure Urinary Access System | Emmy Medical | 2014-12-19 | 130 | 0 |
| K120766 | ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) | Prosurg, Inc. | 2012-09-11 | 182 | 0 |
| K093725 | CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE | Canada Endoscope Corporation | 2010-08-30 | 270 | 0 |
| K093665 | ENDO SMARTCAP | Byrne Medical, Inc. | 2009-12-15 | 20 | 0 |
| K090814 | MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND | Gyrus Acmi, Inc. | 2009-04-20 | 26 | 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