Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMD Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide | FMD Co., Ltd. | 2026-03-20 | 30 | 0 |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | FMD Co., Ltd. | 2024-06-13 | 118 | 0 |
| K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Ext | FMD Co., Ltd. | 2022-05-27 | 311 | 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