510(k) Report

Devices descending from K935370

29 later devices reach Miniox IA Oxygen Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973282Handi Oxygen AnalyzerCeramatec, Inc.199828—
+2K063488MAXO2 CUMaxtec, Inc.20077—
+2K051857Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates200516—
+2K023565OxicheckCaradyne, Ltd.200310—
+3K122290Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH20133—
+3K081601Veo Multigas Monitor for Pocket PCPhasein AB200812—
+3K072845Precision FlowVapotherm, Inc.200828
+3K063167Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG)Phasein AB20072—
+3K040484MAXO2+, Model a and AEMaxtec, Inc.20049—
+4K254078HVT 2.0Vapotherm, Inc.20260—
+4K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+4K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.20180—
+4K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH20140—
+4K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+4K123043Irma C02 Model 200101; Irma AX 200601Phasein AB201211—
+4K111640Precision Flow (R) - HelioxVapotherm, Inc.201101
+4K072813Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)Phasein AB20071—
+5K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.20250—
+5K201590EMMA CapnographMasimo Corporation20210—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K160481Vivo 60Breas Medical AB201672
+5K140264MADMThornhill Research, Inc.20150—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—