510(k) Report

Devices descending from K033823

23 later devices reach Respironics Custom II Oral Appliance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH200622—
+2K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.20180—
+2K152660HypnospadSomnics, Inc.20160—
+2K140777Zquiet-SASleeping Well, LLC20140—
+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—
+3K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+3K160531NoiselezzFirma Ingemarsson20160—
+3K150566OnirisSas Oniris20160—
+3K140663TherasnoreDistar, LLC20140—
+3K093407Zquiet MouthpieceSleeping Well, LLC20108—
+4K261912SnØreNegatØrDnB Innovations, LLC20260—
+4K203462Advanced Dental ApplianceDasoft Partners20210—
+4K180124ZQuietSleeping Well, LLC20186—
+5K210910Snore BanditSnorebandit, LLC20210—
+5K201719Vital SleepThe Snore Reliever Company, LLC20211—
+5K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—