Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Promedical Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
229 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091097 | PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 | Promedical Products Co., Ltd. | 2009-05-27 | 41 | 0 |
| K080629 | PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND C | Promedical Products Co., Ltd. | 2008-10-20 | 229 | 0 |
| K080627 | PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A | Promedical Products Co., Ltd. | 2008-04-24 | 50 | 0 |
| K042111 | PROMEDICAL SURGICAL GOWNS | Promedical Products Co., Ltd. | 2004-12-10 | 127 | 0 |
| K042131 | PROMEDICAL SURGICAL DRAPES | Promedical Products Co., Ltd. | 2004-12-10 | 123 | 0 |
| K042137 | PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVE | Promedical Products Co., Ltd. | 2004-10-05 | 57 | 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