510(k) Report

Devices descending from K952292

134 later devices reach Puritan-Bennett Companion Nasal Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961626Solo Cpap SystemRespironics, Inc.1996114—
+1K960518The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp.199630—
+2K982242Invacare CpapInvacare Corp.19992—
+2K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc.199829—
+2K973161Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd.1998110—
+3K071069Mini Cpap Device and Humidifier AccessoryViasys Sleep Systems, LLC20070—
+3K052597Breathex Omega Cpap Device, Model 322Hoffman Laboratories, LLC20057—
+3K041823Pioneer U121 Series CpapMerits Health Products Co., Ltd.20050—
+3K040941Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd.200498—
+3K041035Hoffrichter Trend 110 Cpap Device with Aquatrend Iii Cpap Humidifier Accessory for TrendHoffrichter GmbH20041—
+3K031064Invacare Polaris EX Cpap, Model ISP3000Invacare Corp.20040—
+3K014074Hoffrichter Vector, Vector Plus, Vector BI-Vevel, Vector BI-Level Plus, Scalar, Scalar…Hoffrichter GmbH20032—
+3K991150Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt.199928—
+4K121374ZI BlowerDeshum Medical20131—
+4K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+4K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+4K081029Sleepstyle 200 Auto Series HC254Fisher & Paykel Healthcare, Ltd.20084—
+4K053486Trend 200 Cpap Device, Model 5CP201; Trendset PC Software, Model TrendsetHoffrichter GmbH20060—
+4K050904Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd.200525—
+4K041900HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd.200474—
+4K020886Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett, Goodknight 420S…Tyco Healthcare Nancy20025—
+4K993584Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt.200022—
+5K150365Cloud9 SystemInsleep Technologies, LLC20150—
+5K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+5K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+5K132127Transcend AutoSomnetics International, Inc.20131—
+5K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+5K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+5K094040F&P Icon Series CpapFisher & Paykel Healthcare, Ltd.201011
+5K100104Hybernite Rainout Control SystemPlastiflex Group NV20106—
+5K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd.201030—
+5K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+5K080439Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model…Mallinckrodt Developpement France20081—
+5K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+5K041819Goodknight 425, Modelm-114500-00Mallinckrodt Developpement France20042—
+5K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc.200320—
+5K031470Puritan Bennett, Goodknight 420 Evolution, Model M-113903-USTyco Healthcare Nancy20030—
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+6K173193F&P SleepStyleFisher & Paykel Healthcare, Ltd.20180—
+6K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+6K122705Humicare D900Grundler GmbH20131—
+6K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+6K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+6K1122713B Willow3B Products, LLC201211
+6K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+6K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+6K103316FlowrestVapotherm, Inc.20113—
+6K091947S8 Aspen with H4I PlusResmed, Ltd.200931—
+6K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+6K082237Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France20080—
+6K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+6K063476Breas Isleep 20IBreas Medical AB200712—
+6K061057Breas Isleep 20+Breas Medical AB20060—
+6K050072Goodknight 425STNellcor Puritan Bennett, Inc.20051—
+6K042945Aura Cpap SystemAeiomed, Inc.20056—
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+7K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+7K133766Humicare D900Gruendler GmbH20140—
+7K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+7K140124S9 EloueraResmed Corp20148—
+7K132606S9 Cronulla for HerResmed, Ltd.20140—
+7K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+7K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+7K123511S9 Vpap TXResmed, Ltd.20131—
+7K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+7K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+7K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+7K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+7K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+8K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+8K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+8K233707HFT150Invent Medical Corporation20240—
+8K222292F&P myAirvo 3Fisher & Paykel Healthcare20240—
+8K223863BONHAWA Respiratory HumidifierTelesair, Inc.20230—
+8K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+8K203357HVT 2.0Vapotherm, Inc.20211—
+8K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—
+8K203126S10 KirraResmed Pty, Ltd.20200—
+8K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+8K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+8K180474TNI softFlow 50Tni Medical AG20180—
+8K160836Menai SystemResmed, Ltd.20166—
+8K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+8K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+8K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+8K140159S9 Wanda Vpap STResmed, Ltd.20142—
+8K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+8K113801Vpap AdaptResmed Corp20125—
+8K113288Vpap ST-aResmed, Ltd.20127—
+8K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+8K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+9K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+9K254078HVT 2.0Vapotherm, Inc.20260—
+9K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+9K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+9K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+9K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—