Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Centers For Disease Control and Prevention (CDC) · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
298 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: | Centers For Disease Control and Prevention (CDC) | 2018-07-30 | 28 | 0 |
| K170940 | Rickettsia Real-time PCR Assay | Centers For Disease Control and Prevention (CDC) | 2017-06-29 | 91 | 0 |
| DEN160016 | Variola virus Real-Time PCR Assay | Centers For Disease Control and Prevention (CDC) | 2017-02-06 | 298 | 0 |
| K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, | Centers For Disease Control and Prevention (CDC) | 2016-06-30 | 24 | 0 |
| K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel | Centers For Disease Control and Prevention (CDC) | 2015-12-01 | 32 | 0 |
| K140426 | ANTHRACIS REAL-TIME PCR ASSAY | Centers For Disease Control and Prevention (CDC) | 2014-05-22 | 92 | 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