Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ross Product Div. Abbott Laboratories · 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) |
|---|---|---|---|---|---|
| K031407 | ROSS EMBRACE ENTERAL PUMP | Ross Product Div. Abbott Laboratories | 2003-05-20 | 15 | 1 |
| K003047 | AMBULATORY ENTERAL NUTRITION PUMP | Ross Product Div. Abbott Laboratories | 2001-06-12 | 256 | 0 |
| K992494 | FLEXIFLO ENTERAL FEEDING TUBE | Ross Product Div. Abbott Laboratories | 1999-08-25 | 30 | 0 |
| K990863 | MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE | Ross Product Div. Abbott Laboratories | 1999-04-06 | 21 | 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