Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Shina Med Corporation · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

236 daysmedian FDA review time
345 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250510Sure-Fine Insulin SyringesShina Med Corporation2025-10-152360
K250658SureFine Pen NeedleShina Med Corporation2025-04-03290
K231165Shina Syringe; Shina Safety SyringeShina Med Corporation2023-10-271850
K210848Sure-Fine Insulin SyringesShina Med Corporation2022-03-013440
K191531Sure-Fine Insulin SyringesShina Med Corporation2019-09-06881
K152879Sure-Fine Insulin SyringesShina Med Corporation2016-09-093450
K152877SureFine Pen NeedleShina Med Corporation2016-06-072510

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