Volu Sol Medical Industries: FDA clearances and approvals
Volu Sol Medical Industries has 66 FDA 510(k) clearances (first 1979, latest 1982), across 52 product codes in 6 review panels. Median 510(k) review time: 17 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 | 3 |
| HYJ | Hematoxylin | 3 | 3 |
| HZJ | Stain, Papanicolau | 3 | 3 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 3 | 3 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 2 | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 2 | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| HZH | Orange G | 2 | 2 |
| IAF | Wright'S Stain | 2 | 2 |
| KQG | Instrument, Coagulation | 2 | 2 |
Plus 42 more product codes.
Review panels
- Clinical Chemistry (24)
- Pathology (22)
- Microbiology (10)
- Hematology (6)
- Immunology (3)
- Clinical Toxicology (1)
Most recent Volu Sol Medical Industries 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K822129 | VOLU-SOL BOVINS FIXATIVE | IGN | 1982-08-05 | 17 |
| K822128 | VOLU-SOL SINGLE DIFFERENTIAL STAIN | ICN | 1982-08-05 | 17 |
| K822127 | VOLU-SOL ZENKERS FIXATIVE | IFH | 1982-08-05 | 17 |
| K822126 | VOLU-SOL CARNOY FLUID | IGM | 1982-08-05 | 17 |
| K822038 | VOLU-SOL ORANGE G-6(GILLS-MOD | HZH | 1982-08-03 | 22 |
| K822037 | VOLU-SOL TAP WATER SUBSTITUTE | PPM | 1982-08-03 | 22 |
| K822036 | VOLU-SOL DECALCIFER | KDX | 1982-08-03 | 22 |
| K822035 | VOLU-SOL GILLS EA | HZJ | 1982-08-03 | 22 |
| K812906 | ELVI BICLOT 816 | KQG | 1982-07-22 | 276 |
| K821541 | HEMATOXYLIN III | HYJ | 1982-06-10 | 17 |
56 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Volu Sol Medical Industries.
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 Volu Sol Medical Industries have?
Volu Sol Medical Industries has 66 FDA 510(k) clearances (first 1979, latest 1982), across 52 product codes in 6 review panels.
How long does FDA take to clear Volu Sol Medical Industries's 510(k)s?
The median time from FDA receipt to decision across Volu Sol Medical Industries's cleared 510(k)s is 17 days.
What devices does Volu Sol Medical Industries make?
Its most frequent FDA product codes are CGX (Alkaline Picrate, Colorimetry, Creatinine, 3); HYJ (Hematoxylin, 3); HZJ (Stain, Papanicolau, 3).
Has Volu Sol Medical Industries had device recalls?
openFDA lists no recalls under a recalling firm name matching Volu Sol Medical Industries. Related entities may recall under other names.
Next steps
- See all 66 Volu Sol Medical Industries clearances with predicates and recalls
- Run predicate analysis for product code CGX, Volu Sol Medical Industries'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.