510(k) · Cleared
ClearedMonoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for Immunoenzymatic Staining (Product Code NO. MO751)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dako Corp. · DEH Lambda, Antigen, Antiserum, Control
Cleared on Nov 6, 1997 as substantially equivalent to K896918 (Dako Corp., 1990) after a 325-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Nov 6, 1997
- Review
- 325 days
- Class
- Class II
- Product code
- DEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896918 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK896918 Mouse Anti-Human Leucocyte Antigen & Dako Pap KitDako Corp. · 1990
- This deviceK965022 Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for…Dako Corp. · 1997
- Descendant · cites it directly · 0 of its ownK172471 VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172471VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896918 | Mouse Anti-Human Leucocyte Antigen & Dako Pap Kit | Dako Corp. | 1990 | — |
| 0 (this device) | K965022 | Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for… | Dako Corp. | 1997 | — |
| +1 | K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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 |
|---|---|---|---|
| * | K896918 | Mouse Anti-Human Leucocyte Antigen & Dako Pap KitSummary page 1…fication is under the Hematology and Pathology devices panel, Division of Clinical Laboratory Devices. DAKO Monocional Mouse Anti-Human LCA (Product Code No. M0701, FDA K896918/B) 1) Monoclonal Mouse Anti-Human Ki-1 antigen, CD30, Clone Ber-H2 (Product Code No. MO0751) is a mouse anti-human monoclonal an… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | 2018 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K172471 (Ventana Medical Systems, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DEH devicesDEH Lambda, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Monoclonal mouse anti-human Ki-1 antigen, CD30, Clone Ber-H2 (Ber-H2), may be used as one member of a panel of antibodies to aid in the differential diagnosis of large anaplastic cells of undetermined origin. This antibody stains cell membranes of most cases of anaplastic large cell lymphomas (ALCL), often called Ki-1 lymphomas. It also stains cell membranes and/or cytoplasm of most Hodgkin's lymphomas. Ber-H2 is a valuable aid in the assessment of…
Read the full statement (168 words)
Monoclonal mouse anti-human Ki-1 antigen, CD30, Clone Ber-H2 (Ber-H2), may be used as one member of a panel of antibodies to aid in the differential diagnosis of large anaplastic cells of undetermined origin. This antibody stains cell membranes of most cases of anaplastic large cell lymphomas (ALCL), often called Ki-1 lymphomas. It also stains cell membranes and/or cytoplasm of most Hodgkin's lymphomas. Ber-H2 is a valuable aid in the assessment of cutaneous lymphoid infiltrates, particularly when large atypical cells are present. Most nonhcmatolymphoid neoplasms are negative with Ber-H2, although there are scveral significant exceptions. Membrane positivity is seen with embryonal carcinomas, and weak, diffuse cytoplasmic positivity is seen in pancreatic and salivary gland carcinomas.
The staining pattern is most often described as strong membranous and weaker cytoplasinic, specifically paranuclcar dot-positivity of the Golgi region. The weak, diffuse cytoplasmic staining is considered to be unexpected, non-specific labeling. It may be reduced or removed by changing the protcasc pretreatment of the paraffin sections and/or further dilution of the Ber-H2 antibody.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965022: Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for Immunoenzymatic Staining (Product Code NO. MO751).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965022
Report an extraction error
Are you the manufacturer?
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