510(k) Report

Devices descending from K071560

10 later devices reach Provent Nasal Dilator, Model BR2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+1K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+1K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+2K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+2K180619BongoInnomed Healthscience, Inc.20181—
+2K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+2K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+2K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+3K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+4K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—