510(k) Report

Devices descending from K030985

20 later devices reach Breas PV 10I Cpap System, Model PV 10I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063476Breas Isleep 20IBreas Medical AB200712—
+1K061057Breas Isleep 20+Breas Medical AB20060—
+1K042945Aura Cpap SystemAeiomed, Inc.20056—
+2K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+2K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K150365Cloud9 SystemInsleep Technologies, LLC20150—
+3K132127Transcend AutoSomnetics International, Inc.20131—
+3K121374ZI BlowerDeshum Medical20131—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+3K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+4K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+4K180619BongoInnomed Healthscience, Inc.20181—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—