Vanaray Laboratories, Inc.: FDA clearances and approvals
Vanaray Laboratories, Inc. has 10 FDA 510(k) clearances (first 1980, latest 1981), across 3 product codes in 2 review panels. Median 510(k) review time: 64 days.
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 |
|---|---|---|---|
| GYB | Media, Electroconductive | 7 | 7 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
Plus 1 more product codes.
Review panels
Most recent Vanaray Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802647 | ECA GEL PROUDUCT REFORMULATION | GYB | 1981-01-08 | 80 |
| K802648 | UCA CREAM PRODUCT REFORMULATION | GYB | 1980-11-26 | 37 |
| K802650 | UCA LOTION PRODUCT REFORMULATION | GYB | 1980-11-12 | 23 |
| K802649 | UCA GEL PRODUCT REFORMAULATION | GYB | 1980-11-12 | 23 |
| K801383 | ECA CREAM REFORMULATION | GYB | 1980-06-17 | 6 |
| K792490 | UCA LOTION | — | 1980-02-22 | 81 |
| K792492 | UCA GEL | IYO | 1980-02-05 | 64 |
| K792491 | ECA CREAM | GYB | 1980-02-05 | 64 |
| K792489 | UCA CREAM | IYO | 1980-02-05 | 64 |
| K792488 | ECA GEL | GYB | 1980-02-05 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Vanaray Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vanaray Laboratories, Inc. have?
Vanaray Laboratories, Inc. has 10 FDA 510(k) clearances (first 1980, latest 1981), across 3 product codes in 2 review panels.
How long does FDA take to clear Vanaray Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vanaray Laboratories, Inc.'s cleared 510(k)s is 64 days.
What devices does Vanaray Laboratories, Inc. make?
Its most frequent FDA product codes are GYB (Media, Electroconductive, 7); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Has Vanaray Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vanaray Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 10 Vanaray Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GYB, Vanaray Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.