Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PJB · 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) |
|---|---|---|---|---|---|
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and | Stereotaxis, Inc. | 2020-03-05 | 113 | 0 |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workst | Stereotaxis, Inc. | 2019-10-30 | 30 | 0 |
| K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019-09-06 | 309 | 0 |
| DEN140009 | AMIGO REMOTE CATHETER SYSTEM | Catheter Robotics, Inc. | 2014-12-18 | 303 | 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