Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LLD · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880072 | PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM | Pharmacia Deltec, Inc. | 1988-03-29 | 78 | 0 |
| K864552 | PORT-A-CATH IMPLANTABLE CATHETER SYSTEM | Pharmacia, Inc. | 1987-03-31 | 132 | 0 |
| K862412 | INTESTOPLANT | Burron Medical Products, Inc. | 1986-11-13 | 141 | 0 |
| K832906 | PORT-A-CATH IMPLANTABLE CATHETER SYS | Pharmacia, Inc. | 1984-03-06 | 190 | 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