Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IYO — Predicate Candidate Screening
894 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
274 days90th percentile
894clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 | 291 | 0 |
| K260190 | ARTHUR | ROPCA ApS | 2026-06-18 | 147 | 0 |
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | 2026-04-17 | 274 | 0 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 | 114 | 0 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | 2026-03-04 | 89 | 0 |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026-02-24 | 92 | 0 |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-C | Eieling Technology (Shenzhen) Limited | 2026-02-06 | 130 | 0 |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025-09-30 | 237 | 0 |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | 2025-08-01 | 171 | 0 |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 | 276 | 0 |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | 2025-06-26 | 21 | 0 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mi | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 | 181 | 0 |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025-05-23 | 154 | 0 |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025-04-23 | 166 | 0 |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Li | Eieling Technology (Shenzhen) Limited | 2024-11-19 | 89 | 0 |
| K241029 | SpineUs™ System | Verdure Imaging | 2024-10-07 | 175 | 0 |
| K233977 | Velacur | Sonic Incytes | 2024-09-04 | 261 | 0 |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. | 2024-06-26 | 232 | 0 |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-06-12 | 212 | 0 |
| K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | 2024-05-03 | 228 | 0 |
| K232302 | Pocket III | Quantel Medical | 2024-04-26 | 269 | 0 |
| K231677 | EdgeFlow UH10 | Edgecare, Inc. | 2024-03-06 | 271 | 0 |
| K240146 | BD Prevue™ II Peripheral Vascular Access System | Bard Access Systems, Inc. | 2024-02-18 | 30 | 0 |
| K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Li | Eieling Technology Limited | 2024-02-12 | 131 | 0 |
| K230986 | Bladder Scanner | Avantsonic Technology Co., Ltd. | 2023-12-29 | 267 | 0 |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Steri | Ultrasound Biotechnology (Shanghai) Co., Ltd. | 2023-12-21 | 177 | 0 |
| K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023-12-21 | 140 | 0 |
| K230511 | K3900 Ultrasound Imaging System | Maui Imaging | 2023-10-25 | 243 | 0 |
| K232459 | Velacur | Sonic Incytes | 2023-09-12 | 28 | 0 |
| K231283 | SiteRite™ 9 Ultrasound System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2023-09-11 | 131 | 0 |
| K223448 | Bladder Scanner Model: BVT02 | Xuzhou Kaixin Electronic Instrument Co., Ltd. | 2023-07-07 | 234 | 0 |
| K223287 | Velacur | Sonic Incytes | 2023-04-20 | 177 | 0 |
| K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | 2023-03-31 | 445 | 0 |
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+ | Echosens | 2023-03-02 | 64 | 0 |
| K222787 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3 | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2023-01-09 | 116 | 0 |
| K220933 | QT Scanner 2000 Model A | Qt Imaging, Inc. | 2022-08-31 | 153 | 0 |
| K213488 | Bladder Scanner, Model Name:M5 | Suzhou Peaksonic Medical Technology Co., Ltd. | 2022-07-01 | 242 | 0 |
| K211529 | NAVIRFA Scope | Navifus Corporation | 2022-05-05 | 353 | 0 |
| K213620 | ATUSA™ Automated 3D Breast Ultrasound System | Isono Health, Inc. | 2022-04-22 | 157 | 0 |
| K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | 2022-03-16 | 190 | 0 |
| K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021-12-22 | 64 | 0 |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dua | Infraredx, Inc. | 2021-12-07 | 64 | 0 |
| K213070 | MD-320W Ultrasound Biomicroscope | MEDA Co., Ltd. | 2021-11-18 | 56 | 0 |
| K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | 2021-11-15 | 46 | 0 |
| K211726 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021-11-05 | 154 | 0 |
| K212035 | FibroScan 230 | Echosens | 2021-07-30 | 30 | 0 |
| K210468 | SC1 Handheld Ultrasound Imaging System (Model: SC1) | Fcu Co., Ltd. | 2021-07-23 | 157 | 0 |
| K203659 | iSR'obot Mona Lisa 1.0 | Biobot Surgical Pte., Ltd. | 2021-07-08 | 205 | 0 |
| K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021-06-25 | 65 | 0 |
| K211623 | THD Procto Software System | Thd Spa | 2021-06-24 | 29 | 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