Finemedix Co., Ltd.: FDA clearances and approvals
Finemedix Co., Ltd. has 11 FDA 510(k) clearances (first 2018, latest 2026), across 7 product codes in 2 review panels. Median 510(k) review time: 178 days. Since 2017 its median was 178 days, against 155 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 222 |
| 2019 | 2 | 170 |
| 2020 | 1 | 251 |
| 2021 | 1 | 163 |
| 2022 | 0 | — |
| 2023 | 1 | 59 |
| 2024 | 1 | 29 |
| 2025 | 2 | 192 |
| 2026 | 1 | 338 |
Review time against the same product codes
Since 2017, Finemedix Co., Ltd.'s cleared 510(k)s took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FCG | Biopsy Needle | 3 | 3 |
| OCX | Endoscopic Irrigation/Suction System | 2 | 2 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 2 | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
| KTI | Bronchoscope Accessory | 1 | 1 |
Review panels
Most recent Finemedix Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251478 | ClearTip TBNA Type | KTI | 2026-04-16 | 338 |
| K250994 | ClearTip FNA and FNB Types | FCG | 2025-08-21 | 142 |
| K242857 | ClearHemograsper | KGE | 2025-05-21 | 243 |
| K242134 | ClearCap Distal Attachment | OCX | 2024-08-20 | 29 |
| K231267 | ClearTip | FCG | 2023-06-30 | 59 |
| K202616 | ClearCap Distal Attachment | OCX | 2021-02-19 | 163 |
| K200217 | ClearEndoclip | PKL | 2020-10-05 | 251 |
| K183021 | ClearEndoclip | PKL | 2019-06-28 | 239 |
| K183289 | ClearGrasp Snare | FDI | 2019-03-06 | 100 |
| K181690 | Clear-Jet Injection Catheter | FBK | 2018-12-21 | 178 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Finemedix Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Finemedix Co., Ltd. have?
Finemedix Co., Ltd. has 11 FDA 510(k) clearances (first 2018, latest 2026), across 7 product codes in 2 review panels.
How long does FDA take to clear Finemedix Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Finemedix Co., Ltd.'s cleared 510(k)s is 178 days. Since 2017: 178 days, versus 155 days for all cleared 510(k)s in the same product codes.
What devices does Finemedix Co., Ltd. make?
Its most frequent FDA product codes are FCG (Biopsy Needle, 3); OCX (Endoscopic Irrigation/Suction System, 2); PKL (Hemostatic Metal Clip For The Gi Tract, 2).
Has Finemedix Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Finemedix Co., Ltd. Related entities may recall under other names.
Next steps
- See all 11 Finemedix Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FCG, Finemedix Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.