PMA · Approved
Recalled · 2011Ventana Medical Systems Pathway Anti-C-Kit (9.7) Primary Antibody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · NKF Immunohistochemistry Antibody Assay, C-Kit
Approved on Aug 11, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 596-day review. It has been recalled 2 times.
- Decided
- Aug 11, 2004
- Review
- 596 days
- Class
- Class III
- Product code
- NKF
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020055 has 31 supplements since 2007: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2007 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 7 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2011 | Not classified | Z-2717-2011 | Pending | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885… |
| May 16, 2011 | Not classified | Z-2716-2011 | Pending | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NKF devicesNKF Immunohistochemistry Antibody Assay, C-Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKF
Too few NKF 510(k)s in any year since 2007 to give a median.
Recalls per year · NKF
No recall names NKF since 2007.
Adverse event reports per year · NKF
No MAUDE report names NKF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 7 | — | 0 | 0 |
| 2014 | 4 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 4 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P020055 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020055: Ventana Medical Systems Pathway Anti-C-Kit (9.7) Primary Antibody.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020055
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026