Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Starmed Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
283 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026-05-26 | 263 | 0 |
| K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | 2025-11-17 | 179 | 0 |
| K234140 | VIVA combo RF System (VIVA combo RF System) | Starmed Co., Ltd. | 2024-01-30 | 32 | 0 |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, | Starmed Co., Ltd. | 2023-10-25 | 28 | 0 |
| K222997 | VVR Generator system | Starmed Co., Ltd. | 2023-10-25 | 392 | 0 |
| K203795 | Star RF Electrode, VIVA RF Electrode | Starmed Co., Ltd. | 2021-04-01 | 94 | 0 |
| K181758 | ELRA Electrode | Starmed Co., Ltd. | 2019-04-11 | 283 | 0 |
| K183538 | VIVA combo RF System | Starmed Co., Ltd. | 2019-01-17 | 29 | 0 |
| K181249 | EUSRA RF Electrode | Starmed Co., Ltd. | 2018-09-04 | 117 | 0 |
| K172012 | star RF Electrode, VIVA RF Electrode | Starmed Co., Ltd. | 2018-03-14 | 254 | 0 |
| K163450 | VIVA combo RF System | Starmed Co., Ltd. | 2017-03-08 | 90 | 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