510(k) Report

Devices descending from K932799

13 later devices reach Single Use Manual Resuscitator Peep Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983920Ems Peep Valves- AdjustableEngineered Medical Systems199912—
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+2K053466Hsiner ResuscitatorHsiner Co., Ltd.20060—
+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—
+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—