Ventana Medical Systems, Inc.: FDA clearances and approvals
Ventana Medical Systems, Inc. has 46 FDA 510(k) clearances (first 1992, latest 2024), plus 13 PMA and 3 De Novo decisions, across 25 product codes in 4 review panels. Median 510(k) review time: 272 days. Since 2017 its median was 208 days, against 158 days for all cleared 510(k)s in the same product codes. openFDA lists 56 product recalls by a recalling firm named Ventana Medical Systems, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 248 |
| 2013 | 4 | 460 |
| 2014 | 1 | 24 |
| 2015 | 1 | 275 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 266 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 151 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 181 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ventana Medical Systems, Inc.'s cleared 510(k)s took a median 208 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DEH | Lambda, Antigen, Antiserum, Control | 17 | 17 |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 6 | 6 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 5 | 5 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 4 | 4 |
| DEY | Igm, Peroxidase, Antigen, Antiserum, Control | 3 | 3 |
| DFD | Kappa, Peroxidase, Antigen, Antiserum, Control | 3 | 3 |
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | 3 | 0 |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | 2 | 0 |
| PRB | Cervical Intraepithelial Neoplasia (Cin) Test System | 2 | 1 |
| PSY | Whole Slide Imaging System | 2 | 2 |
Plus 15 more product codes.
Review panels
- Pathology (38)
- Immunology (22)
- Medical Genetics (1)
- Microbiology (1)
Most recent Ventana Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242783 | Roche Digital Pathology Dx | PSY | 2024-12-17 | 92 |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | PSY | 2024-06-14 | 270 |
| K212176 | CINtec Histology | PRB | 2021-12-10 | 151 |
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | DEH | 2018-05-08 | 266 |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | OEO | 2015-07-16 | 275 |
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | NQN | 2014-03-20 | 24 |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | NQN | 2013-11-22 | 268 |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | NQN | 2013-09-26 | 492 |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | NQN | 2013-09-19 | 427 |
| K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | NOT | 2013-09-06 | 519 |
36 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240025 | De Novo | Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit | 2024-12-05 |
| P230018 | PMA | VENTANA CLDN18 (43-14A) RxDx Assay | 2024-10-18 |
| P220006 | PMA | VENTANA FOLR1 (FOLR-2.1) RxDx Assay | 2022-11-14 |
| P200019 | PMA | VENTANA MMR RxDx Panel | 2021-04-22 |
| P190031 | PMA | HER2 Dual ISH DNA Probe Cocktail | 2020-07-28 |
Recalls
56 product recalls in 19 recall events; 5 initiated in the last five years. Most recent: 2026-04-20.
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 Ventana Medical Systems, Inc. have?
Ventana Medical Systems, Inc. has 46 FDA 510(k) clearances (first 1992, latest 2024), plus 13 PMA and 3 De Novo decisions, across 25 product codes in 4 review panels.
How long does FDA take to clear Ventana Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ventana Medical Systems, Inc.'s cleared 510(k)s is 272 days. Since 2017: 208 days, versus 158 days for all cleared 510(k)s in the same product codes.
What devices does Ventana Medical Systems, Inc. make?
Its most frequent FDA product codes are DEH (Lambda, Antigen, Antiserum, Control, 17); NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity, 6); DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control, 5).
Has Ventana Medical Systems, Inc. had device recalls?
openFDA lists 56 product recalls in 19 recall events by a recalling firm whose name matches Ventana Medical Systems, Inc; the most recent began 2026-04-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 46 Ventana Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DEH, Ventana Medical Systems, 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.