Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ross Products — 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) |
|---|---|---|---|---|---|
| K011467 | ROSS EMBRACE PUMP SET | Ross Products | 2001-08-10 | 88 | 0 |
| K972437 | ROSS ENTERAL FEEDING TUBE | Ross Products | 1998-01-26 | 210 | 0 |
| K950017 | FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM | Ross Products | 1997-03-14 | 801 | 0 |
| K951429 | FLEXIFLO 6.1 ENTERAL NUTRITION PUMP | Ross Products | 1995-12-22 | 269 | 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