510(k) Report

Devices descending from K033822

35 later devices reach Respironics Custom I Oral Appliance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+1K113569ApnearxApnea Science Corporation20124—
+1K060795SomnofitStrategic Counsel Sarl20060—
+1K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH200622—
+2K223901ApneaRX ProApnea Sciences Coporation20231—
+2K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited20180—
+2K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.20180—
+2K162192BlueProBluesom20160—
+2K152660HypnospadSomnics, Inc.20160—
+2K140777Zquiet-SASleeping Well, LLC20140—
+2K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+2K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+2K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+2K121761Somnoguard SP SoftTomed Dr. Toussaint GmbH20122—
+2K120372DR Greenburgs Hybrid VacuumAlways More Marketing, Inc.20120—
+2K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+2K113022PuresleepSleep Science Partners, Inc.20121—
+2K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+2K090503Zquiet MouthpieceSleeping Well, LLC200910—
+3K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+3K253868QuietLab ProQuietLab, LLC20250—
+3K250122SleepRight Snore AidSplintek, Inc.20250—
+3K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+3K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+3K160531NoiselezzFirma Ingemarsson20160—
+3K150566OnirisSas Oniris20160—
+3K140663TherasnoreDistar, LLC20140—
+3K093407Zquiet MouthpieceSleeping Well, LLC20108—
+4K261912SnØreNegatØrDnB Innovations, LLC20260—
+4K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+4K203462Advanced Dental ApplianceDasoft Partners20210—
+4K180124ZQuietSleeping Well, LLC20186—
+5K210910Snore BanditSnorebandit, LLC20210—
+5K201719Vital SleepThe Snore Reliever Company, LLC20211—
+5K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—