Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Catheter Innovations, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
139 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021704 | VAXCEL PICC WITH PASV VALVE TECHNOLOGY | Catheter Innovations, Inc. | 2002-06-06 | 14 | 8 |
| K010349 | DUAL LUMEN MIDLINE CATHETER | Catheter Innovations, Inc. | 2001-02-28 | 23 | 0 |
| K003642 | PLACEMENT-PLUS | Catheter Innovations, Inc. | 2000-12-20 | 23 | 0 |
| K993860 | CATHETER INNOVATIONS IMPLANTABLE PORT | Catheter Innovations, Inc. | 1999-12-03 | 18 | 0 |
| K991897 | CATHETER INNOVATIONS IMPLANTABLE PORT | Catheter Innovations, Inc. | 1999-10-21 | 139 | 9 |
| K981382 | PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL | Catheter Innovations, Inc. | 1998-05-01 | 15 | 0 |
| K981368 | PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC | Catheter Innovations, Inc. | 1998-05-01 | 16 | 0 |
| K980127 | 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INC | Catheter Innovations, Inc. | 1998-03-11 | 56 | 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