Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Denver Biomaterials, Inc. — 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) |
|---|---|---|---|---|---|
| K973129 | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACC | Denver Biomaterials, Inc. | 1998-03-17 | 208 | 0 |
| K971753 | DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DEN | Denver Biomaterials, Inc. | 1997-06-27 | 46 | 0 |
| K962814 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomaterials, Inc. | 1997-04-14 | 269 | 0 |
| K960456 | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEED | Denver Biomaterials, Inc. | 1996-04-01 | 62 | 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