510(k) Report

Devices descending from K113291

4 later devices reach Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH20143—
+2K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+3K180991AG 100sHospitech Respiration, Ltd.20181—
+4K221477AG100sHospitech Respiration, Ltd.20220—