De Novo · Granted
GrantedNon-Variola Orthopoxvirus Real-Time PCR Primer and Probe Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centers for Disease Control and Prevention · PBK Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
Granted on Sep 21, 2018 as a new device type through De Novo after a 4,266-day review.
- Decided
- Sep 21, 2018
- Review
- 4,266 days
- Class
- Class II
- Product code
- PBK
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PBK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PBK device
- #1 K221834 Non-variola Orthopoxvirus Real-time PCR Primer…score 7.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PBK devicesPBK Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PBK
3in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PBK
2in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBK
No recall names PBK since 2007.
Adverse event reports per year · PBK
No MAUDE report names PBK since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 2 | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN070001 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN070001: Non-Variola Orthopoxvirus Real-Time PCR Primer and Probe Set.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN070001
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026