Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ventana Medical Systems, Inc. · Predicate Candidate Screening
48 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
275 daysmedian FDA review time
1069 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242783 | Roche Digital Pathology Dx | Ventana Medical Systems, Inc. | 2024-12-17 | 92 | 1 |
| DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507 | Ventana Medical Systems, Inc. | 2024-12-05 | 190 | 0 |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. | 2024-06-14 | 270 | 1 |
| K212176 | CINtec Histology | Ventana Medical Systems, Inc. | 2021-12-10 | 151 | 0 |
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems, Inc. | 2018-05-08 | 266 | 0 |
| DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | Ventana Medical Systems, Inc. | 2017-03-04 | 285 | 0 |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | Ventana Medical Systems, Inc. | 2015-07-16 | 275 | 0 |
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINE | Ventana Medical Systems, Inc. | 2014-03-20 | 24 | 0 |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | Ventana Medical Systems, Inc. | 2013-11-22 | 268 | 0 |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | 2013-09-26 | 492 | 0 |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | Ventana Medical Systems, Inc. | 2013-09-19 | 427 | 0 |
| K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Ventana Medical Systems, Inc. | 2013-09-06 | 519 | 0 |
| K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMA | Ventana Medical Systems, Inc. | 2012-12-17 | 719 | 1 |
| K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) | Ventana Medical Systems, Inc. | 2012-06-01 | 28 | 0 |
| K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | Ventana Medical Systems, Inc. | 2012-04-19 | 293 | 0 |
| K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) | Ventana Medical Systems, Inc. | 2012-03-05 | 248 | 0 |
| K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Ventana Medical Systems, Inc. | 2012-02-22 | 245 | 0 |
| K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | 2011-10-12 | 132 | 0 |
| K101234 | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PR | Ventana Medical Systems, Inc. | 2011-08-25 | 479 | 1 |
| K990618 | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) | Ventana Medical Systems, Inc. | 1999-07-23 | 148 | 2 |
| K940583 | VENTANA CD45 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-10-20 | 1350 | 0 |
| K973389 | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOC | Ventana Medical Systems, Inc. | 1997-10-03 | 85 | 0 |
| K973392 | CHEMMATE LAMBDA | Ventana Medical Systems, Inc. | 1997-10-03 | 86 | 0 |
| K973391 | CHEMMATE KAPPA | Ventana Medical Systems, Inc. | 1997-10-03 | 85 | 0 |
| K973390 | CHEMMATE L26 (CD20) | Ventana Medical Systems, Inc. | 1997-10-03 | 85 | 0 |
| K973393 | CHEMMATE LCA | Ventana Medical Systems, Inc. | 1997-09-25 | 86 | 0 |
| K941514 | VENTANA ANTI-S100 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-25 | 1123 | 0 |
| K941170 | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-22 | 1135 | 0 |
| K941707 | ANTI-MUSCLE ACTIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-21 | 1111 | 0 |
| K941784 | VENTANA ANTI-CD8 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-14 | 1040 | 0 |
| K941604 | VENTANA ANTI-CD4 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-14 | 1050 | 0 |
| K941516 | VENTANNA ANTI-DESMIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-10 | 1049 | 0 |
| K941397 | ANTI-VIMENTIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-10 | 1056 | 0 |
| K940242 | VENTANA CEA PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-12-23 | 1069 | 0 |
| K941782 | VENTANA ANTI-CD5 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-09-10 | 883 | 0 |
| K941505 | VENTANNA ANTI-CD3 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-05-30 | 793 | 0 |
| K941173 | ANTI-KERATIN-HMW PRIMARY ANTI-BODY | Ventana Medical Systems, Inc. | 1996-03-22 | 739 | 0 |
| K935161 | KERATIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-03-22 | 875 | 0 |
| K940331 | KERATIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-02-26 | 763 | 0 |
| K940424 | VENTANA BLUE DETECTION KIT | Ventana Medical Systems, Inc. | 1995-11-06 | 644 | 0 |
| K940243 | VENTANA EMA PRIMARY ANDIBODY | Ventana Medical Systems, Inc. | 1994-09-07 | 231 | 0 |
| K931979 | VENTANA NEGATIVE CONTROL REAGENT | Ventana Medical Systems, Inc. | 1994-03-30 | 342 | 0 |
| K932386 | VENTANA RED DETECTION KIT | Ventana Medical Systems, Inc. | 1993-08-09 | 84 | 0 |
| K932326 | PSA ANTIBODY KIT | Ventana Medical Systems, Inc. | 1993-08-06 | 100 | 0 |
| K924578 | PSA ANTIBODY KIT | Ventana Medical Systems, Inc. | 1993-02-05 | 148 | 0 |
| K924629 | PAP ANTIBODY KIT | Ventana Medical Systems, Inc. | 1993-02-04 | 143 | 0 |
| K920600 | DAB DETECTION KIT | Ventana Medical Systems, Inc. | 1992-05-11 | 90 | 0 |
| K920566 | AEC DETECTION KIT | Ventana Medical Systems, Inc. | 1992-05-08 | 91 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda