Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Steris Corporations · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
150 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203630 | BioGuard Air/Water and Suction Valves | Steris Corporations | 2021-01-08 | 28 | 0 |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTE | Steris Corporations | 2019-03-22 | 59 | 0 |
| K183295 | Celerity HP Chemical Indicator (CI) | Steris Corporations | 2019-01-04 | 38 | 0 |
| K183300 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 B | Steris Corporations | 2019-01-03 | 37 | 0 |
| K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-On | Steris Corporations | 2018-11-20 | 29 | 0 |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | Steris Corporations | 2018-04-04 | 56 | 0 |
| K172748 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 B | Steris Corporations | 2018-02-09 | 150 | 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