Vanaray Laboratories, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Vanaray Laboratories, Inc.” (first 1980, latest 1981), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| 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 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 Vanaray Laboratories, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Vanaray Laboratories, Inc.” (first 1980, latest 1981), 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 Vanaray Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vanaray Laboratories, Inc. is 64 days.
Which FDA product codes appear under Vanaray Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are GYB (Media, Electroconductive, 7); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
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. 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.