510(k) Report

Devices descending from K010263

141 later devices reach Remstar Plus Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K242485EveryWareBreas Medical AB20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K212263Luna G3 BPAP System3B Medical, Inc.20220—
+6K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K200565GalapogosResmed Corp20213—
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K181053Care OrchestratorRespironics, Inc.20191—
+6K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+6K163665MATRx plusZephyr Sleep Technologies20173—
+6K160481Vivo 60Breas Medical AB201672
+6K152068Astral 100/150Resmed, Ltd.20161Class I
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K123511S9 Vpap TXResmed, Ltd.20131—
+6K123897K Series Cpap SystemsCurative Medical, Inc.20132—
+6K122324Vpap S-aResmed, Ltd.20120—
+6K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+6K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+7K242447Falcon HSTCompumedics Limited20250—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K241216myAirResmed Corp20242—
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+7K192624ApneaTrakCadwell Industries, Inc.20200—
+7K181996MATRx PlusZephyr Sleep Technologies20182—
+7K172875Astral 100/150Resmed, Ltd.20180Class I
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+7K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+7K131702K Series Cpap SystemsCurative Medical, Inc.20130—
+7K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+7K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+7K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+8K250624myAirResmed Corp20251—
+8K191925MATRx PlusZephyr Sleep Technologies20191—
+9K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+9K200695MATRx plusZephyr Sleep Technologies20200—