Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Ject Corp. · 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) |
|---|---|---|---|---|---|
| K991294 | MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEE | Medi-Ject Corp. | 1999-04-23 | 8 | 0 |
| K962956 | MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM | Medi-Ject Corp. | 1996-10-07 | 69 | 0 |
| K960285 | MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDR | Medi-Ject Corp. | 1996-04-17 | 89 | 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