Vygon Corp.: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Vygon Corp.” (first 1985, latest 2025), across 20 product codes in 6 review panels. Median 510(k) review time under this name: 144 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 | 1 | 250 |
| 2013 | 0 | — |
| 2014 | 1 | 99 |
| 2015 | 0 | — |
| 2016 | 1 | 274 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 268 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vygon Corp. took a median 268 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 11 | 11 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 9 | 9 |
| FPD | Tube, Feeding | 4 | 4 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| BSY | Catheters, Suction, Tracheobronchial | 3 | 3 |
| FOS | Catheter, Umbilical Artery | 3 | 3 |
| DYB | Introducer, Catheter | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | 2 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
Plus 10 more product codes.
Review panels
- General Hospital (27)
- Gastroenterology and Urology (10)
- Anesthesiology (6)
- Cardiovascular (3)
- General and Plastic Surgery (3)
- Clinical Toxicology (2)
Most recent Vygon Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241587 | pilot TLS | LJS | 2025-02-26 | 268 |
| K151237 | Nutrisafe 2- ENFit Adaptor | PIO | 2016-02-09 | 274 |
| K141026 | LEADERFLEX | FOZ | 2014-07-30 | 99 |
| K121105 | NUTRISAFE 2 FEEDING TUBE | FPD | 2012-12-18 | 250 |
| K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | FPD | 2011-10-13 | 631 |
| K073493 | HEPATOSTAT SET | GAM | 2008-05-06 | 146 |
| K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | FOZ | 2007-11-30 | 261 |
| K061796 | HEPATOSTAT SET, MODEL 760X | GAM | 2006-11-02 | 129 |
| K061250 | MULTICATH EXPERT | FOZ | 2006-09-29 | 148 |
| K062425 | LIFECATH S PICC AND MIDLINE CATHETER | LJS | 2006-09-15 | 28 |
41 earlier clearances. See the full list in Caduvo.
Recalls
23 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2014-08-28.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Vygon USA (4 510(k)s)
- Vygon Us, LLC (3 510(k)s)
- Vygon SA (2 510(k)s)
- Vygon Neuro (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vygon Corp.?
FDA lists 51 510(k) clearances under the applicant name “Vygon Corp.” (first 1985, latest 2025), across 20 product codes in 6 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 Vygon Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vygon Corp. is 144 days.
Which FDA product codes appear under Vygon Corp.?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 11); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 9); FPD (Tube, Feeding, 4).
Next steps
- See all 51 Vygon Corp. clearances with predicates and recalls
- Run predicate analysis for product code LJS, Vygon 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.