Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioject, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
867 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090003 | ZETAJET | Bioject, Inc. | 2009-04-02 | 90 | 1 |
| K050734 | COOL.CLICK | Bioject, Inc. | 2005-06-03 | 74 | 0 |
| K010623 | RECONSTITUTION KIT & VIAL CONNECTOR | Bioject, Inc. | 2001-04-05 | 34 | 0 |
| K003908 | SEROJET | Bioject, Inc. | 2001-03-08 | 79 | 0 |
| K994384 | CLICKER | Bioject, Inc. | 2000-06-22 | 177 | 0 |
| K960373 | BIOJECTOR 2000 MODEL 1B02000 | Bioject, Inc. | 1997-03-05 | 404 | 0 |
| K963012 | BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) | Bioject, Inc. | 1996-10-15 | 74 | 0 |
| K920631 | BIOJECT JET INJECTION SYSTEM | Bioject, Inc. | 1994-06-28 | 867 | 0 |
| K861687 | BIOJECTOR SYRINGE SYSTEM | Bioject, Inc. | 1987-04-23 | 356 | 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