Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PBK · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022-08-30 | 6 | 0 |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022-06-24 | 1 | 0 |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022-06-10 | 2 | 0 |
| DEN070001 | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | 2018-09-21 | 0 | |
| K181205 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2018-09-20 | 136 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda