510(k) · Cleared
ClearedNon-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
Cleared on Sep 20, 2018 as substantially equivalent to DEN060008 (Centers for Disease Control and Prevention, 2006) after a 136-day review. Its family tree reaches back 1 generation to 2006. 3 later devices descend from it.
- Decided
- Sep 20, 2018
- Review
- 136 days
- Class
- Class II
- Product code
- PBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN060008 (2006). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN060008 Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and…Centers for Disease Control and Prevention · 2006
- This deviceK181205 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention · 2018
- Descendant · cites it directly · 2 of its ownK221658 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention · 2022
- Descendant · 2 generations on · 1 of its ownK221834 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention · 2022
- Descendant · 3 generations on · 0 of its ownK222558 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention · 2022
Most influential descendants
Showing 3 of 3 · See all- K221658Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention · 2022 · cites it directly2descendants
- K221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention · 2022 · 2 generations on1descendant
- K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN060008 | Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2006 | — |
| 0 (this device) | K181205 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2018 | — |
| +1 | K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022 | — |
| +2 | K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022 | — |
| +3 | K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 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 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
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 |
|---|---|---|---|
| * | DEN060008 | Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set Our reading of the summary gave K053469, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060008, Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR… (Centers for Disease Control and Prevention), granted Feb 3, 2006; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | 2022 | 2 |
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?
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 | — |
What is it indicated for?
The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular or vesicular rash specimens and viral cell culture lysates submitted to a Laboratory Response Network (LRN) reference laboratory. The assay detects non-variola Orthopoxvirus DNA, including Vaccinia, Cowpox, Monkeypox and Ectromelia viruses at varying concentrations.…
Read the full statement (214 words)
The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular or vesicular rash specimens and viral cell culture lysates submitted to a Laboratory Response Network (LRN) reference laboratory. The assay detects non-variola Orthopoxvirus DNA, including Vaccinia, Cowpox, Monkeypox and Ectromelia viruses at varying concentrations. This assay does not differentiate Vaccinia virus or Monkeypox virus from other Orthopoxviruses detected by this assay and does not detect Variola virus. Refer to the CDC algorithm, Acute, Generalized Vesicular or Pustular Rash Illness Testing Protocol in the United States for recommended testing and evaluation algorithms for patients presenting with acute, generalized pustular or vesicular rash illness.
Results of this assay are for the presumptive identification of non-variola Orthopoxvirus DNA. These results must be used in conjunction with other diagnostic assays and clinical observations to diagnose Orthopoxvirus infection. The assay should only be used to test specimens with low/moderate risk of smallpox. If a high risk of smallpox exists, viral culture should not be attempted. Negative results obtained with this device do not preclude Variola virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Use is limited to Laboratory Response Network (LRN) designated laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181205: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181205
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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