510(k) Report

Devices descending from DEN220042

2 later devices reach Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251559InstaTRU Instant Biological Indicator for Steam (IBI-05)True Indicating, LLC20260—
+1K252306Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process…Steritec Products20260—