# PBK: Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

- Device class: 2; regulation: 21 CFR 866.3315; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 2 days (middle half 2–4)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 2
- 2022: 3

## Most-cited predicates
- K181205: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (2018), cited by 1
- K221834: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (2022), cited by 1
- K221658: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (2022), cited by 1

Source page: https://510kreport.com/product-code/PBK
Data by year (CSV): https://510kreport.com/product-code/PBK.csv