510(k) Report

Devices descending from K033276

68 later devices reach Vpap Iii ST-a through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113288Vpap ST-aResmed, Ltd.20127—
+1K093731Vpap Iii ST-aResmed, Ltd.20100—
+1K092186Vpap TXResmed, Ltd.200918—
+1K060105Vpap Iii ST-a/Kidsta Mask SystemResmed, Ltd.200653—
+1K051364Vpap AdaptResmed, Ltd.200536—
+2K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+2K153061Juno VPAP ST-AResmed, Ltd.20163—
+2K123511S9 Vpap TXResmed, Ltd.20131—
+2K122324Vpap S-aResmed, Ltd.20120—
+2K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+2K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+2K113714Vpap TXResmed, Ltd.20120—
+2K112914Vpap TXResmed, Ltd.20110—
+2K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+2K103167Stellar 150Resmed Germany, Inc.201120—
+2K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+2K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+2K090935Minime Pediatric MaskSleepnet Corporation20095—
+2K080797Humidaire 2IResmed, Ltd.20082—
+2K063540Bipap AutosvRespironics, Inc.200713—
+2K063533Bipap SynchronyRespironics, Inc.200730—
+3K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+3K213169BPAP SystemBMC Medical Co., Ltd.20220—
+3K161492Juno VPAP ST-AResmed, Ltd.20171—
+3K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+3K140159S9 Wanda Vpap STResmed, Ltd.20142—
+3K131388Transcend Heated HumidifierSomnetics International, Inc.20131—
+3K113801Vpap AdaptResmed Corp20125—
+3K113640Stellar 150Resmed Germany, Inc.20121—
+3K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+3K102224Pixi Pediatric MaskResmed, Ltd.20103—
+3K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group20090Class I
+3K092043Bipap Synchrony 2Respironics, Inc.20094—
+3K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group20090Class I
+3K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group2007282
+4K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+4K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+4K203126S10 KirraResmed Pty, Ltd.20200—
+4K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+4K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+4K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+4K140279S9 GreenhillsResmed, Ltd.20142—
+4K122715Stellar 150Resmed Germany, Inc.20130Class I
+4K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+4K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+4K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+4K103395Performax Total Face MaskRespironics, Inc.20110—
+4K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+4K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+4K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+4K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+5K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K180619BongoInnomed Healthscience, Inc.20181—
+5K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+5K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+5K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+5K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+5K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—