510(k) Report

Devices descending from K063125

5 later devices reach Filterflo Hepa; Thermoflo Hepa (Filter / Hme) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122—
+1K093426Bact-Trap Hepa MidiPharma Systems AB20100—
+1K083702Trach-AssistMergenet Medical20090—
+2K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131—
+3K233713Pilling Tracheostomy TubesTeleflex Medical20240—