Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terragene S.A. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
267 daysmedian FDA review time
742 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242453 | Terragene® Bionova® Photon Process Challenge Device with uni | Terragene S.A. | 2024-12-12 | 115 | 0 |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT9 | Terragene S.A. | 2024-09-18 | 495 | 0 |
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terra | Terragene S.A. | 2024-07-12 | 742 | 0 |
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), | Terragene S.A. | 2024-04-05 | 266 | 0 |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terra | Terragene S.A. | 2023-02-28 | 267 | 0 |
| K200272 | Terragene Chemdye | Terragene S.A. | 2020-06-30 | 147 | 0 |
| K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Te | Terragene S.A. | 2019-09-13 | 149 | 1 |
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terr | Terragene S.A. | 2017-11-02 | 314 | 2 |
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