Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unilife Medical Solutions Limited · 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) |
|---|---|---|---|---|---|
| K100998 | 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 | Unilife Medical Solutions Limited | 2010-08-30 | 140 | 0 |
| K093400 | 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 | Unilife Medical Solutions Limited | 2010-04-01 | 150 | 0 |
| K080877 | 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE | Unilife Medical Solutions Limited | 2008-10-21 | 204 | 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