510(k) · Cleared
ClearedDako Labeled Streptavidin-Biotin 2 Kit, and Envision
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 Jul 5, 1996 as substantially equivalent to K924726 (Dako Corp., 1994) after a 435-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 5, 1996
- Review
- 435 days
- Class
- Class II
- Product code
- DEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924726 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK924726 Dako Mouse Anti-Human B-Cell (Dako-C020-L26 Mono AntiDako Corp. · 1994
- This deviceK951965 Dako Labeled Streptavidin-Biotin 2 Kit, and EnvisionDako Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924726 | Dako Mouse Anti-Human B-Cell (Dako-C020-L26 Mono Anti | Dako Corp. | 1994 | — |
| 0 (this device) | K951965 | Dako Labeled Streptavidin-Biotin 2 Kit, and Envision | Dako Corp. | 1996 | — |
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 |
|---|---|---|---|
| * | K924726 | Dako Mouse Anti-Human B-Cell (Dako-C020-L26 Mono AntiSummary page 1…forms a complex with peroxidase-conjugated streptavidin molecules. This kit is very similar to the original DAKO LSAB® Kit, HRP (KO680) previously cleared in submission K924726. Refinements to the LSAB® 2 Kit include the elimination of a separate protein blocking reagent incubation and reconfigured substr… | 1994 |
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?
- Its one ancestor has no 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.
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 | — |
https://510kreport.com/device/K951965 · printed Nov 3, 2026
Cite this page
510(k) Report. “K951965: Dako Labeled Streptavidin-Biotin 2 Kit, and Envision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K951965
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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