Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OOU — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
221 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172282 | Panther Fusion Paraflu Assay | Hologic, Inc. | 2017-10-23 | 87 | 0 |
| K153223 | ProParaFlu+ Assay | Hologic, Inc. | 2015-12-09 | 33 | 0 |
| K141927 | LYRA PARAINFLUENZA VIRUS ASSAY | Quidel Corporation | 2014-10-09 | 85 | 0 |
| K132238 | PROPARAFLU+ ASSAY | Gen-Probe Prodesse, Inc. | 2013-08-26 | 39 | 0 |
| K091053 | PROPARAFLU+ASSAY | Prodesse, Inc. | 2009-11-20 | 221 | 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