Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FED — Predicate Candidate Screening
101 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
244 days90th percentile
101clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260965 | CVAC Aspiration System | Calyxo, Inc. | 2026-04-13 | 21 | 0 |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PU | Zhuhai Pusen Medical Technology Co., Ltd. | 2026-04-06 | 48 | 0 |
| K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | 2025-10-07 | 54 | 0 |
| K250128 | Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. | 2025-09-19 | 245 | 0 |
| K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | 2025-09-05 | 231 | 0 |
| K250695 | Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-07-08 | 123 | 0 |
| K251599 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-03 | 37 | 0 |
| K250585 | LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. | 2025-06-27 | 120 | 0 |
| K250452 | CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0 | MacroLux Medical Technology Co., Ltd. | 2025-06-02 | 104 | 0 |
| K243710 | Disposable ureteral access sheath | Shenzhen Trious Medical Technology Co., Ltd. | 2025-04-11 | 130 | 0 |
| K250517 | Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M00 | Boston Scientific Corporation | 2025-03-21 | 28 | 0 |
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Mode | Dornier Medtech America | 2025-01-31 | 50 | 0 |
| K243025 | Ureteral Access Sheath | Seplou (Zhuhai) Co., Ltd. | 2025-01-30 | 125 | 0 |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL | Coloplast Corp. | 2024-11-12 | 111 | 0 |
| K243091 | Over-tube (TR-1108A) | Fujifilm Corporation | 2024-11-01 | 32 | 0 |
| K240167 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-08 | 260 | 0 |
| K241181 | Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited | 2024-08-02 | 95 | 0 |
| K240853 | Pathfinder® CR System | Neptune Medical, Inc. | 2024-06-27 | 91 | 0 |
| K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | 2024-02-02 | 100 | 1 |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-15 | FUJIFILM Healthcare Americas Corporation | 2023-09-15 | 182 | 0 |
| K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | 2023-08-02 | 138 | 0 |
| K230801 | Pathfinder Endoscope Overtube with Balloon Device | Neptune Medical, Inc. | 2023-07-28 | 127 | 0 |
| K220065 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-25 | 135 | 0 |
| K200770 | Mini PCNL-System | Trokamed GmbH | 2021-07-30 | 492 | 4 |
| K211301 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2021-05-28 | 29 | 0 |
| K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | 2021-04-30 | 189 | 0 |
| K203119 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2020-12-09 | 54 | 0 |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | Dornier Medtech America, Inc. | 2020-11-20 | 142 | 0 |
| K200419 | Kalera Vacuum Aspiration Catheter (K-VAC) | Kalera Medical, Inc. | 2020-05-22 | 92 | 0 |
| K192691 | PatCom Single-Use Introducer | H&A Mui Enterprises, Inc. | 2020-02-21 | 148 | 0 |
| K191415 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2019-08-30 | 94 | 0 |
| K191067 | Arc Endocuff Glide AEG110 & AEG120 | Boddingtons Plastics, Ltd. | 2019-05-30 | 38 | 0 |
| K182403 | Peel-Away Introducer | Cook Incorporated | 2019-05-29 | 267 | 0 |
| K182520 | Flexible Overtube | Sumitomo Bakelite Co., Ltd. | 2019-05-15 | 244 | 0 |
| K190030 | Embrella Endoscopic Distal Attachment | Micro-Tech (Nanjing) Co., Ltd. | 2019-03-05 | 57 | 0 |
| K181811 | ReTrace Ureteral Access Sheath | Coloplast A/S | 2018-09-07 | 63 | 0 |
| K173400 | ORISE Tissue Retractor System | Boston Scientific | 2018-02-09 | 101 | 0 |
| K171208 | Trans-anal Introducer | Visionsense, Ltd. | 2018-02-05 | 286 | 0 |
| K172575 | BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscop | Baronova, Inc. | 2018-01-18 | 143 | 0 |
| K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Rele | Cook Incorporated | 2017-12-13 | 142 | 0 |
| K162205 | Arc EndoCuff and Arc EndoCuff Vision | Boddingtons Plastics, Ltd. | 2016-12-09 | 126 | 0 |
| K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016-10-12 | 175 | 0 |
| K160846 | AmplifEYE | Medivators, Inc. | 2016-07-14 | 108 | 0 |
| K160861 | Proxis Ureteral Access Sheath | C.R. Bard, Inc. | 2016-03-31 | 2 | 0 |
| K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016-01-07 | 260 | 0 |
| K151801 | Arc Endocuff Vision | Boddingtons Plastics, Ltd. | 2015-08-13 | 42 | 0 |
| K150083 | Sidecar External Working Channel | C2 Therapeutics | 2015-04-14 | 89 | 0 |
| K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, | Coloplast A/S | 2014-07-24 | 142 | 0 |
| K140323 | NAVIGATOR HD URETERAL ACCESS SHEATH SETS | Boston Scientific | 2014-03-07 | 25 | 0 |
| K131598 | ANAL RECTAL OVERTUBE | United States Endoscopy Group, Inc. | 2014-02-26 | 268 | 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