Vxtra Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Vxtra Corp.” (first 1980, latest 1983), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 47 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 3 | 3 |
| GES | Blade, Scalpel | 2 | 2 |
| HNN | Knife, Ophthalmic | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Vxtra Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832980 | VXTRA OCUTOME KIT | HQC | 1983-10-19 | 47 |
| K832938 | OCUTOME PARATUBING SET | — | 1983-10-19 | 47 |
| K831266 | MICROSURGICAL KNIFE | HNN | 1983-06-10 | 53 |
| K830385 | IRRIGATION/ASPIRATION KIT | HQC | 1983-04-05 | 60 |
| K830379 | PHAKO KIT | HQC | 1983-04-05 | 60 |
| K812620 | ADJUSTABLE MICROSURGICAL KNIFE | HNN | 1981-10-19 | 34 |
| K812526 | MICRO BLADE II | GES | 1981-09-16 | 14 |
| K812160 | MICROSURGICAL BLADE | GES | 1981-08-31 | 33 |
| K800557 | DISPOSABLE PRE-GELLED ELECTROSURGICAL | GEI | 1980-04-21 | 40 |
| K792436 | VXTRA BACK PACK EKG ELECTRODE CAT. NO. | DRX | 1980-02-22 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Vxtra 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 Vxtra Corp.?
FDA lists 10 510(k) clearances under the applicant name “Vxtra Corp.” (first 1980, latest 1983), across 6 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 Vxtra Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vxtra Corp. is 47 days.
Which FDA product codes appear under Vxtra Corp.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 3); GES (Blade, Scalpel, 2); HNN (Knife, Ophthalmic, 2).
Next steps
- See all 10 Vxtra Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Vxtra 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.