Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Dose, Inc. — 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) |
|---|---|---|---|---|---|
| K974431 | CHEMO-SPIKE II RECONSTITUTION DEVICE | Medi-Dose, Inc. | 1998-01-08 | 45 | 0 |
| K952518 | SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE | Medi-Dose, Inc. | 1995-07-28 | 102 | 0 |
| K936015 | DISPOSABLE DISC FILTER | Medi-Dose, Inc. | 1994-12-12 | 361 | 0 |
| K942532 | 2 MICRON AIR ELIMINATING FILTER | Medi-Dose, Inc. | 1994-08-17 | 82 | 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