Agnes Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Agnes Medical Co., Ltd.” (first 2019, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 248 days. Since 2017 the median was 248 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 27 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 651 |
| 2023 | 1 | 136 |
| 2024 | 1 | 339 |
| 2025 | 3 | 248 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Agnes Medical Co., Ltd. took a median 248 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 | 7 | 7 |
Review panels
Most recent Agnes Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250217 | AGNES Ultra | GEI | 2025-09-03 | 222 |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) | GEI | 2025-08-19 | 260 |
| K242469 | RFMagik Lite | GEI | 2025-04-25 | 248 |
| K230837 | PlazMagik | GEI | 2024-02-29 | 339 |
| K223805 | Agnes | GEI | 2023-05-04 | 136 |
| K203013 | AGNES | GEI | 2022-07-14 | 651 |
| K192728 | Agnes | GEI | 2019-10-24 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Agnes Medical Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Agnes Medical Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Agnes Medical Co., Ltd.” (first 2019, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Agnes Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Agnes Medical Co., Ltd. is 248 days. Since 2017: 248 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Agnes Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7).
Next steps
- See all 7 Agnes Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Agnes Medical Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.