Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prodesse, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
221 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091053 | PROPARAFLU+ASSAY | Prodesse, Inc. | 2009-11-20 | 221 | 0 |
| K092500 | MODIFICATION TO PROFLU+ ASSAY | Prodesse, Inc. | 2009-08-20 | 6 | 0 |
| K090239 | PROGASTRO CD ASSAY | Prodesse, Inc. | 2009-04-16 | 73 | 0 |
| K082688 | PRO HMPV+ ASSAY | Prodesse, Inc. | 2008-11-07 | 53 | 0 |
| K081030 | MODIFICATION TO PROFLU+ ASSAY | Prodesse, Inc. | 2008-05-02 | 21 | 0 |
| K073029 | PROFLU+ ASSAY | Prodesse, Inc. | 2008-01-04 | 67 | 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