Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
RF Medical Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232763 | Electrode Handpieces (VCT, RFTV, BMDT series) | RF Medical Co., Ltd. | 2023-10-04 | 26 | 0 |
| K221277 | Mygen M-3004 RF Generator M-3004 | RF Medical Co., Ltd. | 2022-09-02 | 122 | 0 |
| K193355 | Electrodes Handpieces for Mygen V-1000 RF System | RF Medical Co., Ltd. | 2020-08-03 | 243 | 0 |
| K180999 | Mygen V-1000 RF System | RF Medical Co., Ltd. | 2018-12-11 | 239 | 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