Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE DiagSamsung Medison Co., Ltd.2026-07-28890
K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic UltSamsung Medison Co., Ltd.2026-03-27980
K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Samsung Medison Co., Ltd.2026-01-051890
K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound SSamsung Medison Co., Ltd.2025-07-181080
K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound SSamsung Medison Co., Ltd.2025-02-12750
K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound SySamsung Medison Co., Ltd.2024-12-101090
K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic UlSamsung Medison Co., Ltd.2024-11-271030
K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2024-10-11980
K241302SonoSyncSamsung Medison Co., Ltd.2024-08-231060
K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SysSamsung Medison Co., Ltd.2024-06-211070
K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2024-06-121100
K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2023-12-21850
K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic UltrasoSamsung Medison Co., Ltd.2023-10-031090
K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic UlSamsung Medison Co., Ltd.2023-04-211000
K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SySamsung Medison Co., Ltd.2023-02-13980
K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2022-08-22810
K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SySamsung Medison Co., Ltd.2022-06-29860
K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic UltraSamsung Medison Co., Ltd.2022-06-17600
K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2022-05-06950
K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic UlSamsung Medison Co., Ltd.2022-04-05900
K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2021-09-09870
K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2021-09-08770
K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2021-07-091210
K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic UltraSamsung Medison Co., Ltd.2021-06-24850
K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2021-05-13910
K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic UltrasounSamsung Medison Co., Ltd.2021-04-09880
K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2020-10-30570
K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2020-05-07510
K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2020-04-07560
K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2020-01-06830
K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.2019-12-12910
K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic UlSamsung Medison Co., Ltd.2019-12-101060
K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2019-09-19510
K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2019-06-12470
K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2019-06-12540
K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2019-05-22860
K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2019-02-151160
K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2019-01-22990
K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2019-01-081060
K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018-12-18890
K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018-12-041970
K1808835D ViewerSamsung Medison Co., Ltd.2018-05-15410
K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018-05-11860
K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018-03-08940
K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018-02-20990
K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018-02-051260
K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2017-08-241390
K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2017-08-091210
K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2017-08-08250
K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2017-03-28390

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