510(k) Report

Devices descending from K163300

2 later devices reach ThermoShield HME Filter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp20240—
+1K210352GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd.20220—