510(k) Report

Devices descending from K152356

4 later devices reach Sapphire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242485EveryWareBreas Medical AB20250—
+1K183226Care Orchestrator EssenceRespironics, Inc.20190—
+1K181053Care OrchestratorRespironics, Inc.20191—
+2K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—