PMA · Approved
Recalled · 2011Pathway Anti-HCR-2/Ncu (4B5) Rabbit Monoclonal Primary Antibody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · MVC System, Test, Her-2/Neu, Ihc
Approved on Nov 28, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 351-day review. It has been recalled 3 times.
- Decided
- Nov 28, 2000
- Review
- 351 days
- Class
- Class III
- Product code
- MVC
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P990081 has 57 supplements since 2002: 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 |
|---|---|
| 2002 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 4 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 10 |
| 2014 | 6 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 5 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 4 |
| 2026 | 2 |
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 MVC? 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… |
| Sep 17, 2009 | Not classified | Z-1146-2010 | Nonconforming Material/Component | Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MVC devicesMVC System, Test, Her-2/Neu, Ihc: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MVC
Too few MVC 510(k)s in any year since 2007 to give a median.
Recalls per year · MVC
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVC
2in 2021
MAUDE reports naming product code MVC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 4 |
| 2010 | 6 | — | 0 | 0 |
| 2011 | 6 | — | 0 | 0 |
| 2012 | 5 | — | 0 | 2 |
| 2013 | 13 | — | 0 | 2 |
| 2014 | 7 | — | 0 | 1 |
| 2015 | 7 | — | 0 | 4 |
| 2016 | 3 | — | 0 | 3 |
| 2017 | 5 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 7 | — | 0 | 0 |
| 2020 | 6 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 3 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | — | 0 | 0 |
| 2025 | 4 | — | 0 | 0 |
| 2026 | 5 | — | 0 | — |
https://510kreport.com/device/P990081 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990081: Pathway Anti-HCR-2/Ncu (4B5) Rabbit Monoclonal Primary Antibody.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990081
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026