510(k) Report

Devices descending from K191909

2 later devices reach HepaShield Bacterial Viral Breathing System Filter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA20220Class I
+1K210352GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd.20220—