Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pacific Device, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
339 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972464 | VITALMIX PLUS EMPTY I.V. CONTAINER | Pacific Device, Inc. | 1997-11-05 | 127 | 0 |
| K923782 | TRANSFER SET | Pacific Device, Inc. | 1993-07-02 | 339 | 0 |
| K912860 | INTRAVASCULAR ADMINISTRATION SETS | Pacific Device, Inc. | 1991-08-28 | 62 | 0 |
| K912596 | MECONIUM ASPIRATION | Pacific Device, Inc. | 1991-07-30 | 50 | 0 |
| K902482 | VITALMIX (SET & BAG) | Pacific Device, Inc. | 1990-07-02 | 28 | 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