Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtecs (Taiwan) Corp. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown | Medtecs (Taiwan) Corp. | 2022-10-21 | 617 | 0 |
| K203376 | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask | Medtecs (Taiwan) Corp. | 2022-03-02 | 470 | 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