Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cordis Corp., A Johnson & Johnson Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
296 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140438 | MICRO GUIDE CATHETER ELITE | Cordis Corp., A Johnson & Johnson Co. | 2014-11-14 | 266 | 0 |
| K131225 | ADROIT GUIDING CATHETER | Cordis Corp., A Johnson & Johnson Co. | 2013-05-29 | 29 | 1 |
| K091077 | OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER | Cordis Corp., A Johnson & Johnson Co. | 2010-02-04 | 296 | 2 |
| K083814 | OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009-01-13 | 22 | 0 |
| K062531 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMB | Cordis Corp., A Johnson & Johnson Co. | 2006-09-22 | 24 | 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