Class Class II
Terragene® Bionova® BT20 Biological Indicator (K251122)
Description
Terragene® Bionova® BT20 Biological Indicator by Terragene, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251122
Clearance Date2025-08-04
Clearance TypeTraditional
Product CodeFRC
Regulation Number880.2800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251122
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Terragene® Bionova® BT20 Biological Indicator (K251122) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Ter... | Terragene S.A. | 2017 |
Trace the full predicate network for K251122
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.