Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gastroenterology, Urology — Predicate Candidate Screening
11,291 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
140 daysmedian FDA review time
273 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253505 | Zamenix™ P | Roen Surgical, Inc. | 2026-08-07 | 280 | 0 |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | 2026-08-07 | 256 | 0 |
| K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2026-08-07 | 169 | 0 |
| K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 3 | Mozarc Medical Us, LLC | 2026-08-06 | 300 | 0 |
| K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | 2026-08-05 | 331 | 0 |
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical , Ltd. | 2026-08-05 | 139 | 0 |
| K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Fe | Convatec | 2026-08-05 | 152 | 0 |
| K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | 2026-08-05 | 48 | 0 |
| K260572 | Marrow Marxman | Medimetrix, LLC | 2026-08-04 | 166 | 0 |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF- | Olympus Medical Systems Corporation | 2026-07-31 | 112 | 0 |
| K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | 2026-07-31 | 60 | 0 |
| K262200 | Stone Clear (BWSC-LP9-02) | Sonomotion, Inc. | 2026-07-29 | 30 | 0 |
| K253651 | Revi System | Bluewind Medical , Ltd. | 2026-07-28 | 250 | 0 |
| K261399 | ELISIO™-HX | Nipro Medical Corporation | 2026-07-28 | 90 | 0 |
| K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026-07-27 | 136 | 0 |
| K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | 2026-07-24 | 99 | 0 |
| K254180 | PerfusiX-Imaging | LIMIS Development B.V. | 2026-07-24 | 213 | 0 |
| K253541 | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX P | Medical Impact | 2026-07-24 | 252 | 0 |
| K262152 | VS-370CF, VS-370CT | VISION MEDICAL Co., Ltd. | 2026-07-24 | 29 | 0 |
| K261644 | Perfadex Plus | Xvivo Perfusion AB | 2026-07-23 | 66 | 0 |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C | MacroLux Medical Technology Co., Ltd. | 2026-07-20 | 153 | 0 |
| K261573 | ENDOSCOPE HOLDER (182214) | Aktormed GmbH | 2026-07-20 | 69 | 0 |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | 2026-07-17 | 63 | 0 |
| K261658 | LoFric Origo Pro Coudé | Wellspect AB | 2026-07-17 | 59 | 0 |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-07-14 | 89 | 0 |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 Fre | C.R. Bard, Inc. | 2026-07-10 | 246 | 0 |
| K262045 | Luja Soft | Coloplast A.S. | 2026-07-07 | 20 | 0 |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscop | Fujifilm Corporation | 2026-07-02 | 27 | 0 |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC | 2026-07-02 | 50 | 0 |
| K252483 | Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. | 2026-07-01 | 328 | 0 |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-52 | Hangzhou AGS MedTech Co., Ltd. | 2026-06-24 | 267 | 0 |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | 2026-06-24 | 69 | 0 |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single | Hangzhou Jimushi Meditech Co., Ltd. | 2026-06-24 | 138 | 0 |
| K261342 | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | 2026-06-22 | 60 | 0 |
| K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026-06-18 | 148 | 0 |
| K260428 | RIVOS™ EUS Access Device (M00553900) | Boston Scientific Corporation | 2026-06-17 | 127 | 0 |
| K252933 | DYNE PORT | Dyne Medical Group, Inc. | 2026-06-12 | 270 | 0 |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShiel | FloShield, Inc. | 2026-06-11 | 99 | 0 |
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026-06-10 | 121 | 0 |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026-06-04 | 174 | 0 |
| K253984 | Instrument Exit Point on Touch Surgery™ Aide | Covidien, LLC | 2026-06-04 | 174 | 0 |
| K252800 | KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & CO. KG | 2026-06-03 | 273 | 0 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 | 294 | 0 |
| K260456 | VI°Port™ Liver Preservation System | Traferox Technologies, Inc. | 2026-06-01 | 110 | 0 |
| K260262 | Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. | 2026-05-29 | 121 | 0 |
| K254076 | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter K | C.R. Bard, Inc. | 2026-05-29 | 162 | 0 |
| K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026-05-29 | 32 | 0 |
| K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-05-28 | 108 | 0 |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 | 116 | 0 |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026-05-24 | 123 | 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