Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Xeridiem Medical Devices · 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) |
|---|---|---|---|---|---|
| K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFi | Xeridiem Medical Devices | 2017-06-06 | 29 | 0 |
| K130674 | ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE | Xeridiem Medical Devices | 2014-01-13 | 306 | 0 |
| K130611 | ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE | Xeridiem Medical Devices | 2013-12-19 | 287 | 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