Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hosuk Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K021197 | SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 | Hosuk Co., Ltd. | 2002-04-26 | 10 | 10 |
| K002921 | SUREONE INSULIN SYRINGE | Hosuk Co., Ltd. | 2000-10-18 | 29 | 3 |
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