Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OWP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
177 daysmedian FDA review time
675 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181442 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2018-06-13 | 12 | 0 |
| K162945 | VERIFY ASSERT STEAM Process Challenge Device | STERIS Corporation | 2017-04-28 | 189 | 0 |
| K162701 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2017-03-24 | 177 | 0 |
| K163587 | VERIFY Incubator for Assert Self Contained Biological Indica | STERIS Corporation | 2017-03-24 | 94 | 0 |
| DEN110006 | VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR | STERIS Corporation | 2013-07-12 | 675 | 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