Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agnes Medical Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
248 daysmedian FDA review time
651 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250217 | AGNES Ultra | Agnes Medical Co., Ltd. | 2025-09-03 | 222 | 0 |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, | Agnes Medical Co., Ltd. | 2025-08-19 | 260 | 0 |
| K242469 | RFMagik Lite | Agnes Medical Co., Ltd. | 2025-04-25 | 248 | 0 |
| K230837 | PlazMagik | Agnes Medical Co., Ltd. | 2024-02-29 | 339 | 0 |
| K223805 | Agnes | Agnes Medical Co., Ltd. | 2023-05-04 | 136 | 0 |
| K203013 | AGNES | Agnes Medical Co., Ltd. | 2022-07-14 | 651 | 0 |
| K192728 | Agnes | Agnes Medical Co., Ltd. | 2019-10-24 | 27 | 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