Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Finemedix Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
265 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | 2026-04-16 | 338 | 0 |
| K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | 2025-08-21 | 142 | 0 |
| K242857 | ClearHemograsper | Finemedix Co., Ltd. | 2025-05-21 | 243 | 0 |
| K242134 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2024-08-20 | 29 | 0 |
| K231267 | ClearTip | Finemedix Co., Ltd. | 2023-06-30 | 59 | 0 |
| K202616 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2021-02-19 | 163 | 0 |
| K200217 | ClearEndoclip | Finemedix Co., Ltd. | 2020-10-05 | 251 | 0 |
| K183021 | ClearEndoclip | Finemedix Co., Ltd. | 2019-06-28 | 239 | 0 |
| K183289 | ClearGrasp Snare | Finemedix Co., Ltd. | 2019-03-06 | 100 | 0 |
| K181690 | Clear-Jet Injection Catheter | Finemedix Co., Ltd. | 2018-12-21 | 178 | 0 |
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | 2018-11-01 | 265 | 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