Samsung Medison Co., Ltd.: FDA filings under this applicant name
FDA lists 73 510(k) clearances under the applicant name “Samsung Medison Co., Ltd.” (first 2011, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 85 days. Since 2017 the median was 91 days, against 111 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 12 |
| 2013 | 5 | 29 |
| 2014 | 4 | 28 |
| 2015 | 5 | 27 |
| 2016 | 4 | 42 |
| 2017 | 5 | 56 |
| 2018 | 7 | 94 |
| 2019 | 9 | 91 |
| 2020 | 4 | 56 |
| 2021 | 6 | 88 |
| 2022 | 5 | 86 |
| 2023 | 4 | 99 |
| 2024 | 6 | 106 |
| 2025 | 2 | 92 |
| 2026 | 3 | 98 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Samsung Medison Co., Ltd. took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 68 | 68 |
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Radiology (73)
Most recent Samsung Medison Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; | IYN | 2026-07-28 | 89 |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System | IYN | 2026-03-27 | 98 |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | IYN | 2026-01-05 | 189 |
| K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System | IYN | 2025-07-18 | 108 |
| K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System | IYN | 2025-02-12 | 75 |
| K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | IYN | 2024-12-10 | 109 |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | IYN | 2024-11-27 | 103 |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | IYN | 2024-10-11 | 98 |
| K241302 | SonoSync | LLZ | 2024-08-23 | 106 |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | IYN | 2024-06-21 | 107 |
63 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Samsung Medison Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Samsung Electronics Co., Ltd. (42 510(k)s)
- Samsung Sds Co., Ltd. (6 510(k)s)
- Samsung Mobile Display Co., Ltd. (5 510(k)s)
- Samsung Strategy and Innovation Center (Ssic) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Samsung Medison Co., Ltd.?
FDA lists 73 510(k) clearances under the applicant name “Samsung Medison Co., Ltd.” (first 2011, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Samsung Medison Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Samsung Medison Co., Ltd. is 85 days. Since 2017: 91 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Samsung Medison Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 68); LLZ (System, Image Processing, Radiological, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 73 Samsung Medison Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Samsung Medison Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.