Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Corpak, Inc. — 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) |
|---|---|---|---|---|---|
| K964514 | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS | Corpak, Inc. | 1998-06-26 | 605 | 0 |
| K970178 | CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM | Corpak, Inc. | 1997-07-21 | 185 | 0 |
| K944750 | CORFLO 300 PUMP | Corpak, Inc. | 1995-06-19 | 266 | 1 |
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