Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chirana T.Injecta,A.S. · 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) |
|---|---|---|---|---|---|
| K252483 | Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. | 2026-07-01 | 328 | 0 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, | Chirana T.Injecta,A.S. | 2026-04-17 | 269 | 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