Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QVB · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | 2026-06-18 | 393 | 0 |
| K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), V | Steritec Products | 2026-04-22 | 272 | 0 |
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terra | Terragene S.A. | 2024-07-12 | 742 | 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