Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hansen Medical, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
414 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | 2016-09-20 | 169 | 0 |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | 2016-02-01 | 77 | 0 |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory C | Hansen Medical, Inc. | 2015-08-18 | 78 | 0 |
| K151730 | Magellan Robotic System | Hansen Medical, Inc. | 2015-07-23 | 27 | 0 |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | 2015-07-01 | 233 | 0 |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | Hansen Medical, Inc. | 2013-09-27 | 59 | 1 |
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | Hansen Medical, Inc. | 2012-05-29 | 414 | 1 |
| K102168 | SENSEI X ROBOTIC CATHETER SYSTEM | Hansen Medical, Inc. | 2010-10-22 | 81 | 1 |
| K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | Hansen Medical, Inc. | 2009-09-10 | 84 | 1 |
| K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER | Hansen Medical, Inc. | 2009-05-07 | 83 | 1 |
| K082075 | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER | Hansen Medical, Inc. | 2008-08-15 | 23 | 0 |
| K073225 | SENSEI CATHETER CONTROL SYSTEM | Hansen Medical, Inc. | 2008-06-30 | 228 | 1 |
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES | Hansen Medical, Inc. | 2007-05-02 | 600 | 2 |
| K061070 | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR | Hansen Medical, Inc. | 2006-10-13 | 179 | 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