510(k) Report

Devices descending from K852272

7 later devices reach Bivona Tracheostoma Valve II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022125Provox Freehands Hme, Model 7710Atos Medical AB20022—
+1K961449Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH19963—
+2K141380Provox Freehands FlexivoiceAtos Medical AB20140—
+2K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131—
+2K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122—
+2K072582Provox Micron HmeAtos Medical AB20080—
+3K233713Pilling Tracheostomy TubesTeleflex Medical20240—