510(k) Report

Devices descending from K100545

30 later devices reach Sleepright through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212767SleepRight Select-Comfort Dental GuardSplintek, Inc.20210—
+1K103004Snore GuardRanir, LLC201128—
+2K112205Snorerx 9.0Consumer Health Products, Inc.201126—
+2K101155Auradorm (Neuromuscular Sleep)Sleepwright20110—
+3K153200SnoreRxApnea Sciences Corporation201622—
+3K113569ApnearxApnea Science Corporation20124—
+4K223901ApneaRX ProApnea Sciences Coporation20231—
+4K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited20180—
+4K170825SnoreRxApnea Sciences Corporation201721—
+4K162192BlueProBluesom20160—
+5K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte., Ltd.20261—
+5K252161Hushd AveraGood Sleep CO Pte, Ltd.20250—
+5K251628Mandibular Advancement Device L07Dcstar, Inc.20250—
+5K250122SleepRight Snore AidSplintek, Inc.20250—
+5K233850Difiney Anti Snoring DeviceFissiontech, LLC20243—
+5K200657SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc.20212—
+5K203462Advanced Dental ApplianceDasoft Partners20210—
+5K201484Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC20201—
+5K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—
+5K181482myTAP2Airway Management, Inc.20180—
+6K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.20260—
+6K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC20260—
+6K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.20260—
+6K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+6K250353Oniris; Oniris PlusOniris20250—
+6K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLC20251—
+6K231138Aniti-Snore Mouthguard+Oscimed SA20240—
+6K210910Snore BanditSnorebandit, LLC20210—
+7K261912SnØreNegatØrDnB Innovations, LLC20260—
+7K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLC20250—