Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OMN — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
135 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN120013 | PORTRAIT ANALYZER | Great Basin Scientific | 2012-04-30 | 59 | 0 |
| K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | Focus Diagnostics, Inc. | 2012-04-04 | 135 | 0 |
| K110203 | XPERT C. DIFFICLE/EPI ASSAY | Cepheid | 2011-04-07 | 73 | 0 |
| K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | Meridian Bioscience, Inc. | 2011-02-24 | 52 | 2 |
| K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFF | Meridian Bioscience, Inc. | 2010-07-09 | 108 | 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