Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OVY · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | STERIS Corporation | 2023-12-15 | 29 | 0 |
| K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | STERIS Corporation | 2023-09-11 | 88 | 0 |
| K180553 | VERIFY Spore Test Strip for S40 Sterilant | STERIS Corporation | 2018-05-29 | 89 | 0 |
| DEN110002 | SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT | STERIS Corporation | 2012-03-30 | 242 | 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