Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chirana T. Injecta · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242434 | Insulin Syringes | Chirana T. Injecta | 2024-12-24 | 130 | 0 |
| K220614 | MEDOJECT fine Pen Needles | Chirana T. Injecta | 2022-06-15 | 104 | 0 |
| K201044 | CHIRANA Insulin Syringes | Chirana T. Injecta | 2022-01-18 | 637 | 0 |
| K201009 | CHIRAVAC Blood Collection Needles | Chirana T. Injecta | 2021-07-21 | 460 | 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