Navilyst Medical, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Navilyst Medical, Inc.” (first 2009, latest 2017), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 29 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 | 5 | 28 |
| 2013 | 7 | 34 |
| 2014 | 4 | 54 |
| 2015 | 6 | 29 |
| 2016 | 2 | 228 |
| 2017 | 1 | 56 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Navilyst Medical, Inc. took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 16 | 16 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 4 | 4 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 | 1 |
Review panels
Most recent Navilyst Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163452 | PICC Maximal Barrier Nursing Kit | LJS | 2017-02-03 | 56 |
| K161866 | BioFlo Midline Catheter | FOZ | 2016-09-08 | 63 |
| K151239 | NMI DUAL PORT II | LJT | 2016-06-06 | 392 |
| K153228 | NMI Port, NMI Port II | LJT | 2015-12-04 | 28 |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC | LJS | 2015-09-24 | 29 |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter | FGE | 2015-09-24 | 59 |
| K150407 | BioFlo Midline Catheter | FOZ | 2015-05-15 | 86 |
| K150527 | Xcela Power Injectable PICC | LJS | 2015-03-31 | 29 |
| K150448 | NMI PICC III and NMI PICC IV | LJS | 2015-03-19 | 27 |
| K142616 | PICC Maximal Barrier Nursing Kit | LJS | 2014-10-14 | 28 |
25 earlier clearances. See the full list in Caduvo.
Recalls
92 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2015-01-09.
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 Navilyst Medical, Inc.?
FDA lists 35 510(k) clearances under the applicant name “Navilyst Medical, Inc.” (first 2009, latest 2017), across 10 product codes in 3 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 Navilyst Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Navilyst Medical, Inc. is 29 days.
Which FDA product codes appear under Navilyst Medical, Inc.?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 16); FGE (Stents, Drains And Dilators For The Biliary Ducts, 4); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 4).
Next steps
- See all 35 Navilyst Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, Navilyst Medical, Inc.'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.