Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
San-M Package 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) |
|---|---|---|---|---|---|
| K221534 | Surgical Face Masks (Ear Loops And Tie-On) | San-M Package Co., Ltd. | 2022-09-16 | 112 | 0 |
| K160269 | Surgical Face Masks (Ear loops and Tie-on) | San-M Package Co., Ltd. | 2016-09-06 | 217 | 0 |
| K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 | San-M Package Co., Ltd. | 2016-07-15 | 164 | 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