Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fresenius Pharma · 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) |
|---|---|---|---|---|---|
| K914216 | FRENTA II+ ENTERAL FEEDING PUMP | Fresenius Pharma | 1992-03-18 | 181 | 0 |
| K901134 | ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE | Fresenius Pharma | 1990-06-20 | 100 | 0 |
| K901130 | ENTERA-FLO FEEDING TUBE | Fresenius Pharma | 1990-06-01 | 81 | 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