Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medexel 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) |
|---|---|---|---|---|---|
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, | Medexel Co.,Ltd | 2024-03-15 | 266 | 0 |
| K172095 | Autokeeper | Medexel Co.,Ltd | 2018-07-24 | 378 | 0 |
| K152410 | Top Fine Pen Needle | Medexel Co.,Ltd | 2016-02-02 | 160 | 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