510(k) · Cleared
ClearedVENTANA CD30 (Ber-H2) RxDx Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · DEH Lambda, Antigen, Antiserum, Control
Cleared on May 8, 2018 as substantially equivalent to K965022 (Dako Corp., 1997) after a 266-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- May 8, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- DEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896918 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DEH? 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K965022 | Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for Immunoenzymatic…Summary page 4…system. Product Code: DEH Predicate DAKO Corporation’s Monoclonal Mouse Anti-Human Ki-1antigen, CD30, Device Clone Ber-H2 K965022 Device The VENTANA CD30 (Ber-H2) Assay consists of the primary CD30 (Ber- Description H2) antibody, detection reagen… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 20.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All DEH devicesDEH Lambda, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DEH
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · DEH
Too few DEH 510(k)s in any year since 2007 to give a median.
Recalls per year · DEH
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DEH
11in 2025
MAUDE reports naming product code DEH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 2 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 1 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 26 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VENTANA CD30 (Ber-H2) Assay is intended for laboratory use in the qualitative detection of the CD30 protein in
formalin-fixed, paraffin-embedded tissue stained with a VENTANA BenchMark ULTRA instrument and OptiView DAB
IHC Detection Kit. CD30 positive staining may aid in the identification of classical Hodgkin lymphoma (cHL), anaplastic
large cell lymphoma (ALCL) and cutaneous T-cell lymphoma (CTCL). This product should be interpreted by a qualified
pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody
is intended for in vitro diagnostic (IVD) use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172471: VENTANA CD30 (Ber-H2) RxDx Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172471
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026