510(k) Report

Devices descending from K943509

31 later devices reach 7300 Nasal Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K960518The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp.199630—
+2K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc.199829—
+3K991150Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt.199928—
+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—
+5K080439Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model…Mallinckrodt Developpement France20081—
+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—
+6K082237Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France20080—
+6K063476Breas Isleep 20IBreas Medical AB200712—
+6K061057Breas Isleep 20+Breas Medical AB20060—
+6K050072Goodknight 425STNellcor Puritan Bennett, Inc.20051—
+6K042945Aura Cpap SystemAeiomed, Inc.20056—
+7K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+7K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+7K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+8K150365Cloud9 SystemInsleep Technologies, LLC20150—
+8K132127Transcend AutoSomnetics International, Inc.20131—
+8K121374ZI BlowerDeshum Medical20131—
+8K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+8K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+8K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+9K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+9K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+9K180619BongoInnomed Healthscience, Inc.20181—
+9K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+9K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+9K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+10K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+11K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—