510(k) Report

Devices descending from K030440

65 later devices reach Oasys-Oral Airway System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+1K111207Respire Blue SeriesRespire Medical201111—
+1K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+1K060744O'brien Mpa (Mandibular Positioning Applicance)O'Brien Dental Lab, Inc.20060—
+1K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc.200651—
+1K051014Silent Partner Series Osa AppliancesDreamwrx Dental Laboratory20050—
+2K203477ClassicOrthoapnea S.L.20210—
+2K152292Respire Blue Series-EFRespire Medical Holding20150—
+2K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+2K131138Respire Pink Series - HerbstRespire Medical20137—
+2K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+2K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+2K121344NU SleepRh Associates, LLC20120—
+2K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+2K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+2K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+2K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc.200615—
+2K061732TAP-TAirway Management, Inc.200632—
+3K252374Nylon flexTAP (R)Airway Technologies D/B/A Airway Management20250—
+3K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+3K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+3K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+3K180619BongoInnomed Healthscience, Inc.20181—
+3K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+3K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+3K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+3K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+3K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+3K111110Apnea GuardAdvanced Brain Monitoring, Inc.20112—
+3K102521Pantino Pro PositinerSomnomed, Inc.20110—
+3K103076DynaflexDyna Flex201129—
+3K090911Ist Snoring ApplianceDental Crafters20090—
+4K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+4K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+4K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+4K190051TD ClipZephyr Sleep Technologies, Inc.20190—
+4K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+4K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+4K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+4K130130Atg/SM-Osa AppliancesSelane Products, Inc.201317—
+4K113126Acrylic Herbst ApplianceGergens Orthodontic Lab20132—
+4K103704Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc.20120—
+4K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+5K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+5K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+5K214096Respire ClearRespire Medical, LLC20220—
+5K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+5K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+5K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+5K181123ApnoDent ApplianceApnomed, Inc.20180—
+5K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+5K143591Dorsal ApplianceGergens Orthodontic Lab20150—
+5K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+6K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+6K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+6K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+6K191320Slow Wave DS8Slow Wave, Inc.20205—
+7K252942ShaeferHShaeferh, LLC20260—
+7K234089DNA ApplianceVivos Therapeutics20240—
+7K232735EMA 3DEma Sleep Incorporated20241—
+7K233754AIO BreatheAiomega, LLC20241—
+7K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+8K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+8K252525AIO BreatheAiomega, LLC20250—
+8K252698NightGuard Aire MaxNightguard Express, LLC20250—