Navion Biomedical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Navion Biomedical Corp.” (first 1990, latest 1999), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 127 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Navion Biomedical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983476 | BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES | KNT | 1999-03-01 | 150 |
| K973057 | 1.4 FR MAPCATH SENSOR STYLET | LJS | 1997-11-12 | 89 |
| K952626 | MAPWIRE J-TIP SENSOR GUIDEWIRE | LJS | 1995-08-25 | 78 |
| K940385 | NAVIGATOR-MP CATHETER LOCATION INSTRUMENT | FOZ | 1994-06-02 | 127 |
| K901263 | NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM | FOZ | 1990-08-22 | 159 |
Recalls
openFDA lists no recalls under a recalling firm named Navion Biomedical Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Navion Biomedical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Navion Biomedical Corp.” (first 1990, latest 1999), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Navion Biomedical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Navion Biomedical Corp. is 127 days.
Which FDA product codes appear under Navion Biomedical Corp.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 2); KNT (Tubes, Gastrointestinal (And Accessories), 1).
Next steps
- See all 5 Navion Biomedical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Navion Biomedical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.