Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shina Corp. — 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) |
|---|---|---|---|---|---|
| K113186 | STERILE INSULIN PEN NEEDLE | Shina Corp. | 2012-04-12 | 167 | 0 |
| K091167 | SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES | Shina Corp. | 2009-08-06 | 106 | 0 |
| K071947 | VACU-MED BLOOD COLLECTION NEEDLES | Shina Corp. | 2007-10-12 | 91 | 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