Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Navion Biomedical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
159 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983476 | BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES | Navion Biomedical Corp. | 1999-03-01 | 150 | 0 |
| K973057 | 1.4 FR MAPCATH SENSOR STYLET | Navion Biomedical Corp. | 1997-11-12 | 89 | 0 |
| K952626 | MAPWIRE J-TIP SENSOR GUIDEWIRE | Navion Biomedical Corp. | 1995-08-25 | 78 | 0 |
| K940385 | NAVIGATOR-MP CATHETER LOCATION INSTRUMENT | Navion Biomedical Corp. | 1994-06-02 | 127 | 0 |
| K901263 | NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM | Navion Biomedical Corp. | 1990-08-22 | 159 | 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