Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ITX — Predicate Candidate Screening
412 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
319 days90th percentile
412clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260161 | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | 2026-07-30 | 191 | 0 |
| K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026-07-27 | 10 | 0 |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2026-07-24 | 119 | 0 |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R | Olympus Medical Systems Corporation | 2025-09-18 | 178 | 0 |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE U | Olympus Medical Systems Corporation | 2025-07-11 | 120 | 0 |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | 2025-07-02 | 131 | 0 |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2025-06-13 | 115 | 0 |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | 2024-08-30 | 81 | 0 |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024-08-15 | 244 | 0 |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2024-07-03 | 28 | 0 |
| K233109 | TP Pivot Pro™ Needle Guide | Civco Medical Solutions | 2023-12-22 | 86 | 0 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasoni | FUJIFILM Healthcare Americas Corporation | 2023-12-13 | 189 | 0 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 | 151 | 0 |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | 2023-08-02 | 236 | 0 |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing | 2023-05-12 | 270 | 0 |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023-01-11 | 253 | 0 |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022-11-22 | 133 | 0 |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | 2022-06-07 | 256 | 0 |
| K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | 2021-09-13 | 139 | 0 |
| K211969 | EMM Ultrasonic Transducer Cover | Exact Medical Manufacturing | 2021-08-13 | 50 | 0 |
| K201425 | Disposable Intraoperative Probe (DIOP8) | Huntleigh Healthcare Limited | 2021-02-19 | 266 | 0 |
| K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-20 | 120 | 0 |
| K191491 | EZ-Cover | Medxpress.Pro | 2020-06-05 | 366 | 0 |
| K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2020-04-17 | 28 | 0 |
| K190802 | Envision ultrasound pad and cover | Civco Medical Solutions | 2019-05-24 | 56 | 0 |
| K171272 | Cook-Swartz Doppler Flow Probe | Cook Incorporated | 2018-07-17 | 442 | 0 |
| K180970 | Disposable guides KDNG00 | Koelis | 2018-07-10 | 88 | 0 |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD r | Koelis | 2017-07-31 | 116 | 0 |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endova | CIVCO Medical Instruments Co., Inc. | 2017-06-09 | 198 | 0 |
| K170741 | GTK Disposable Needle Guides | Geotek Medikal Ltd Sti | 2017-06-01 | 83 | 0 |
| K171348 | Pinpoint GT Needle Guide Kits | C.R. Bard, Inc. | 2017-05-22 | 14 | 0 |
| K163502 | iSR'obot Biopsy Kit | Biobot Surgical Pte., Ltd. | 2017-05-16 | 153 | 0 |
| K170338 | A-View | Stroke2prevent B.V. | 2017-05-16 | 103 | 0 |
| K152126 | UST-5550-R; UST-5536-R; L43K | Hitachi Aloka Medical America, Inc. | 2016-08-17 | 383 | 0 |
| K160806 | Verza Guidance System | CIVCO Medical Instruments Co., Inc. | 2016-08-05 | 134 | 0 |
| K160414 | Precision Point Biopsy Needle Guide | Corbin Clinical Resources, LLC | 2016-08-01 | 167 | 0 |
| K153212 | Sheathes Ultrasound Probe Covers | Sheathing Technologies, Inc. | 2016-03-04 | 120 | 1 |
| K152403 | Permanent Sled Bag | Boston Scientific | 2015-09-22 | 28 | 0 |
| K142618 | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diag | Hitachi Aloka Medical America, Inc. | 2014-10-16 | 30 | 0 |
| K141334 | REUSABLE GUIDE | Koelis | 2014-07-11 | 51 | 0 |
| K140854 | INTRA-OPERATIVE ULTRASOUND TRANSDUCER | Hitachi Aloka Medical, Ltd. | 2014-06-11 | 69 | 0 |
| K141093 | 6VT-D ULTRASOUND TRANSDUCER | Ge Vingmed Ultrasound AS | 2014-05-15 | 17 | 0 |
| K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEP | CIVCO Medical Instruments Co., Inc. | 2013-09-17 | 146 | 0 |
| K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | CIVCO Medical Instruments Co., Inc. | 2013-06-11 | 14 | 0 |
| K123424 | MDU5 PLUS STERILE BAG | Boston Scientific Corp | 2013-02-20 | 105 | 0 |
| K122921 | C1-6-D ULTRASOUND TRANSDUCER | GE Healthcare | 2012-10-05 | 11 | 0 |
| K122515 | C2-9-D ULTRASOUND TRANSDUCER | GE Healthcare | 2012-09-11 | 25 | 0 |
| K121062 | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULT | Ge Medical System Israel , Ltd. | 2012-08-17 | 133 | 1 |
| K121807 | V5MS TRANSDUCER | Siemens Medical Solutions USA, Inc. | 2012-07-10 | 20 | 1 |
| K113832 | SONICEYE ULTRASOUND TRANSDUCER | Blacktoe Medical Iii, Inc. | 2012-03-06 | 70 | 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