Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Samsung Medison Co., Ltd. — Predicate Candidate Screening
73 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
116 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diag | Samsung Medison Co., Ltd. | 2026-07-28 | 89 | 0 |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ult | Samsung Medison Co., Ltd. | 2026-03-27 | 98 | 0 |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic | Samsung Medison Co., Ltd. | 2026-01-05 | 189 | 0 |
| K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound S | Samsung Medison Co., Ltd. | 2025-07-18 | 108 | 0 |
| K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound S | Samsung Medison Co., Ltd. | 2025-02-12 | 75 | 0 |
| K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound Sy | Samsung Medison Co., Ltd. | 2024-12-10 | 109 | 0 |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ul | Samsung Medison Co., Ltd. | 2024-11-27 | 103 | 0 |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2024-10-11 | 98 | 0 |
| K241302 | SonoSync | Samsung Medison Co., Ltd. | 2024-08-23 | 106 | 0 |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound Sys | Samsung Medison Co., Ltd. | 2024-06-21 | 107 | 0 |
| K240516 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2024-06-12 | 110 | 0 |
| K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023-12-21 | 85 | 0 |
| K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultraso | Samsung Medison Co., Ltd. | 2023-10-03 | 109 | 0 |
| K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ul | Samsung Medison Co., Ltd. | 2023-04-21 | 100 | 0 |
| K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound Sy | Samsung Medison Co., Ltd. | 2023-02-13 | 98 | 0 |
| K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022-08-22 | 81 | 0 |
| K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound Sy | Samsung Medison Co., Ltd. | 2022-06-29 | 86 | 0 |
| K221117 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultra | Samsung Medison Co., Ltd. | 2022-06-17 | 60 | 0 |
| K220269 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022-05-06 | 95 | 0 |
| K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ul | Samsung Medison Co., Ltd. | 2022-04-05 | 90 | 0 |
| K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-09-09 | 87 | 0 |
| K211945 | V8 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-09-08 | 77 | 0 |
| K210713 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-07-09 | 121 | 0 |
| K210959 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultra | Samsung Medison Co., Ltd. | 2021-06-24 | 85 | 0 |
| K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-05-13 | 91 | 0 |
| K210068 | HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasoun | Samsung Medison Co., Ltd. | 2021-04-09 | 88 | 0 |
| K202556 | HS30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020-10-30 | 57 | 0 |
| K200699 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020-05-07 | 51 | 0 |
| K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020-04-07 | 56 | 0 |
| K192903 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020-01-06 | 83 | 0 |
| K192505 | HS50/HS60 Diagnostics Ultrasound System | Samsung Medison Co., Ltd. | 2019-12-12 | 91 | 0 |
| K192319 | HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ul | Samsung Medison Co., Ltd. | 2019-12-10 | 106 | 0 |
| K192030 | RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-09-19 | 51 | 0 |
| K191115 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-06-12 | 47 | 0 |
| K191055 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-06-12 | 54 | 0 |
| K190444 | HERA I10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-05-22 | 86 | 0 |
| K182932 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-02-15 | 116 | 0 |
| K182894 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-01-22 | 99 | 0 |
| K182632 | HS30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-01-08 | 106 | 0 |
| K182595 | HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-12-18 | 89 | 0 |
| K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-12-04 | 197 | 0 |
| K180883 | 5D Viewer | Samsung Medison Co., Ltd. | 2018-05-15 | 41 | 0 |
| K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-05-11 | 86 | 0 |
| K173713 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-03-08 | 94 | 0 |
| K173513 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-02-20 | 99 | 0 |
| K173204 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-02-05 | 126 | 0 |
| K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-08-24 | 139 | 0 |
| K171070 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-08-09 | 121 | 0 |
| K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-08-08 | 25 | 0 |
| K170493 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-03-28 | 39 | 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