Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Polymint Industrial Co. , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
264 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932457 | SPYROGEL WOUND DRESSING | Polymint Industrial Co. , Ltd. | 1994-02-09 | 264 | 0 |
| K931634 | VARIOUS KITS | Polymint Industrial Co. , Ltd. | 1993-11-30 | 243 | 0 |
| K921775 | SPYROFLEX WOUND CLOSURES | Polymint Industrial Co. , Ltd. | 1992-05-19 | 39 | 0 |
| K911649 | MITRASHEER TRANSPLANT DRESSING | Polymint Industrial Co. , Ltd. | 1991-08-07 | 117 | 0 |
| K891644 | SAMBORD LATEX PATIENT EXAMINATION GLOVES | Polymint Industrial Co. , Ltd. | 1989-06-19 | 94 | 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