Starmed Co., Ltd.: FDA clearances and approvals
Starmed Co., Ltd. has 11 FDA 510(k) clearances (first 2017, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time: 117 days. Since 2017 its median was 117 days, against 112 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2018 | 2 | 186 |
| 2019 | 2 | 156 |
| 2020 | 0 | — |
| 2021 | 1 | 94 |
| 2022 | 0 | — |
| 2023 | 2 | 210 |
| 2024 | 1 | 32 |
| 2025 | 1 | 179 |
| 2026 | 1 | 263 |
Review time against the same product codes
Since 2017, Starmed Co., Ltd.'s cleared 510(k)s took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 9 | 9 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
Review panels
Most recent Starmed Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252833 | VIVA combo RF System | GEI | 2026-05-26 | 263 |
| K251566 | TS-RF Generator (STS10) | GEI | 2025-11-17 | 179 |
| K234140 | VIVA combo RF System (VIVA combo RF System) | GEI | 2024-01-30 | 32 |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | KNS | 2023-10-25 | 28 |
| K222997 | VVR Generator system | GEI | 2023-10-25 | 392 |
| K203795 | Star RF Electrode, VIVA RF Electrode | GEI | 2021-04-01 | 94 |
| K181758 | ELRA Electrode | KNS | 2019-04-11 | 283 |
| K183538 | VIVA combo RF System | GEI | 2019-01-17 | 29 |
| K181249 | EUSRA RF Electrode | GEI | 2018-09-04 | 117 |
| K172012 | star RF Electrode, VIVA RF Electrode | GEI | 2018-03-14 | 254 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Starmed Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Starmed Co., Ltd. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06358391: To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. (Recruiting, started 2024-08-21)
Frequently asked questions
How many FDA 510(k) clearances does Starmed Co., Ltd. have?
Starmed Co., Ltd. has 11 FDA 510(k) clearances (first 2017, latest 2026), across 2 product codes in 2 review panels.
How long does FDA take to clear Starmed Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Starmed Co., Ltd.'s cleared 510(k)s is 117 days. Since 2017: 117 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Starmed Co., Ltd. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 9); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 2).
Has Starmed Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Starmed Co., Ltd. Related entities may recall under other names.
Next steps
- See all 11 Starmed Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Starmed Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.