510(k) Report

Devices descending from K954530

55 later devices reach The Silencer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112205Snorerx 9.0Consumer Health Products, Inc.201126—
+1K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH200622—
+1K060122Sleep SplintNakagawa Dental Clinic20060—
+1K033823Respironics Custom II Oral ApplianceRespironics, Inc.200423—
+1K033822Respironics Custom I Oral ApplianceRespironics, Inc.200435—
+2K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.20180—
+2K152660HypnospadSomnics, Inc.20160—
+2K153200SnoreRxApnea Sciences Corporation201622—
+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—
+2K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+2K113569ApnearxApnea Science Corporation20124—
+2K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+2K090503Zquiet MouthpieceSleeping Well, LLC200910—
+2K060795SomnofitStrategic Counsel Sarl20060—
+3K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+3K253868QuietLab ProQuietLab, LLC20250—
+3K223901ApneaRX ProApnea Sciences Coporation20231—
+3K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+3K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited20180—
+3K170825SnoreRxApnea Sciences Corporation201721—
+3K162192BlueProBluesom20160—
+3K160531NoiselezzFirma Ingemarsson20160—
+3K150566OnirisSas Oniris20160—
+3K140663TherasnoreDistar, LLC20140—
+3K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+3K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+3K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+3K093407Zquiet MouthpieceSleeping Well, LLC20108—
+4K261912SnØreNegatØrDnB Innovations, LLC20260—
+4K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte., Ltd.20261—
+4K252161Hushd AveraGood Sleep CO Pte, Ltd.20250—
+4K251628Mandibular Advancement Device L07Dcstar, Inc.20250—
+4K250122SleepRight Snore AidSplintek, Inc.20250—
+4K233850Difiney Anti Snoring DeviceFissiontech, LLC20243—
+4K200657SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc.20212—
+4K203462Advanced Dental ApplianceDasoft Partners20210—
+4K201484Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC20201—
+4K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+4K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—
+4K181482myTAP2Airway Management, Inc.20180—
+4K180124ZQuietSleeping Well, LLC20186—
+5K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.20260—
+5K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC20260—
+5K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.20260—
+5K250353Oniris; Oniris PlusOniris20250—
+5K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLC20251—
+5K231138Aniti-Snore Mouthguard+Oscimed SA20240—
+5K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+5K210910Snore BanditSnorebandit, LLC20210—
+5K201719Vital SleepThe Snore Reliever Company, LLC20211—
+6K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLC20250—