Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Valley West, Inc. — 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) |
|---|---|---|---|---|---|
| K990447 | 1000 PRESSURE INFUSION SIGMACON 1000 | Valley West, Inc. | 1999-05-12 | 89 | 0 |
| K980089 | 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 | Valley West, Inc. | 1998-03-24 | 74 | 0 |
| K973814 | TRUMP-IT II AND MAGNUM 250 | Valley West, Inc. | 1998-01-30 | 115 | 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