Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
White River Concepts — 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) |
|---|---|---|---|---|---|
| K970488 | HYDROCHECK MICRO FILTER | White River Concepts | 1997-11-04 | 267 | 0 |
| K964679 | WHITE RIVER AUTOMATIC BREAST PUMP | White River Concepts | 1997-06-10 | 201 | 0 |
| K971231 | WHITE RIVER MINI MANUAL BREAST PUMP | White River Concepts | 1997-05-19 | 46 | 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