Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- DYJRetainer, Screw Expansion, Orthodontic1Product Code
- DYOBand, Material, Orthodontic1Product Code
- DYTMaintainer, Space Preformed, Orthodontic1Product Code
- DYWBracket, Plastic, Orthodontic2Product Code
- DZBHeadgear, Extraoral, Orthodontic2Product Code
- DZCWire, Orthodontic1Product Code
- DZDTube, Orthodontic1Product Code
- ECIBand, Elastic, Orthodontic1Product Code
- ECMBand, Preformed, Orthodontic1Product Code
- ECNClamp, Wire, Orthodontic1Product Code
- ECOSpring, Orthodontic1Product Code
- EJFBracket, Metal, Orthodontic1Product Code
- KKORing, Teething, Fluid-Filled2Product Code
- KMYPositioner, Tooth, Preformed1Product Code
- LQZDevice, Jaw Repositioning2Product Code
- LRKDevice, Anti-Snoring2Product Code
- K252525AIO Breathe2Cleared 510(K)
- K252698NightGuard Aire Max2Cleared 510(K)
- K253355Difiney Advanced Anti Snoring Device 4.02Cleared 510(K)
- K251784Hushd Pro Z-Link2Cleared 510(K)
- K251628Mandibular Advancement Device L072Cleared 510(K)
- K250028Anti Snore Mouthpiece2Cleared 510(K)
- K243752Double Tube Herbst Appliance2Cleared 510(K)
- K252374Nylon flexTAP(R)2Cleared 510(K)
- K250353Oniris; Oniris Plus2Cleared 510(K)
- K250122SleepRight Snore Aid2Cleared 510(K)
- K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue2Cleared 510(K)
- K234089DNA Appliance2Cleared 510(K)
- K232025Hushd Pro Avera2Cleared 510(K)
- K232735EMA 3D2Cleared 510(K)
- K233850Difiney Anti Snoring Device2Cleared 510(K)
- K240427airVata™2Cleared 510(K)
- K231138Aniti-Snore Mouthguard+2Cleared 510(K)
- K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)2Cleared 510(K)
- K233434Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)2Cleared 510(K)
- K231663The AVEOtsd (Tongue Stabilizing Device) Mouthpiece2Cleared 510(K)
- K223901ApneaRX Pro2Cleared 510(K)
- K223624Emerald Herbst2Cleared 510(K)
- K222872DNA Appliance2Cleared 510(K)
- K220688SilentZPro 2.02Cleared 510(K)
- K222475SNOR LOCK2Cleared 510(K)
- K221322CUSTMBITE Snoring System2Cleared 510(K)
- K222127Soft Palate Elevator2Cleared 510(K)
- K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring2Cleared 510(K)
- K220330Soundly Anti Snoring Device2Cleared 510(K)
- K213088ZQuiet Advance2Cleared 510(K)
- K214096Respire Clear2Cleared 510(K)
- K210636Morpheus2Cleared 510(K)
- K213475Elevo Snoring Intervention Set2Cleared 510(K)
- K211069EndSnorZ Sleep Appliance2Cleared 510(K)
- K200657SmartGuard Anti-Snoring Device2Cleared 510(K)
- K210203mmRNA appliance2Cleared 510(K)
- K210910Snore Bandit2Cleared 510(K)
- K210694Silent Nite Sleep Appliance with the Glidewell Hinge2Cleared 510(K)
- K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)2Cleared 510(K)
- K203477Classic2Cleared 510(K)
- K203462Advanced Dental Appliance2Cleared 510(K)
- K202651NOA Sleep Apnea and Snoring Device2Cleared 510(K)
- K201719Vital Sleep2Cleared 510(K)
- K201484Somnos Anti-Snoring Mouth Guard2Cleared 510(K)
- K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring2Cleared 510(K)
- K202499Diamond Digital Sleep Orthotic (DDSO)2Cleared 510(K)
- K192127Respire Pink AT (Hard, Hard/Soft, EF)2Cleared 510(K)
- K193239MPowRx Snoring Solution (also known as Good Morning Snore Solution)2Cleared 510(K)
- K191618SleepTight Mouthpiece STZ2Cleared 510(K)
- K181416Sapphire Dorsal Comfort Fit2Cleared 510(K)
- K190236O2Vent Optima2Cleared 510(K)
- K183270Silent Nite sl2Cleared 510(K)
- K190687Twilite Appliance2Cleared 510(K)
- K190051TD Clip2Cleared 510(K)
- K183443SomnoDent Avant2Cleared 510(K)
- K190058PureSleep (OTC use)2Cleared 510(K)
- K173064ZAPnea Oral Appliance2Cleared 510(K)
- K182661Kava and Kava with Herbst2Cleared 510(K)
- K180691TrueDorsal Devices2Cleared 510(K)
- K182312Zyppah Anti-Snoring Device2Cleared 510(K)
- K182202SLEEPAPP2Cleared 510(K)
- K181107Elevo® Kit Snoring Intervention Device2Cleared 510(K)
- K181123ApnoDent Appliance2Cleared 510(K)
- K181396Oral Device OA, Oral Device S2Cleared 510(K)
- K181482myTAP22Cleared 510(K)
- K172991Advanced Dental Applicance2Cleared 510(K)
- K173856Express 4 Sleep appliance/CPAP Sidekick appliance2Cleared 510(K)
- K180124ZQuiet2Cleared 510(K)
- K172760REST EAZY Appliance2Cleared 510(K)
- K171576The Panthera Anti-Snoring X3 Device2Cleared 510(K)
- K171529Snorer's Friend2Cleared 510(K)
- K170053Meridian PM2Cleared 510(K)
- K170578True Function Adjustable Herbst Appliances2Cleared 510(K)
- K170825SnoreRx2Cleared 510(K)
- K171316O2Vent W2Cleared 510(K)
- K163580ASD Oral Appliances2Cleared 510(K)
- K170692Respire Pink Series with DentiTrac2Cleared 510(K)
- K161980Fuselier Intraoral Nighttime Device (FIND)2Cleared 510(K)
- K162192BluePro2Cleared 510(K)
- K152660HYPNOSPAD2Cleared 510(K)
- K161832O2VENT T2Cleared 510(K)
- K162306SomnoDent ALPHA2Cleared 510(K)
- K160531Noiselezz2Cleared 510(K)
- K153200SnoreRx2Cleared 510(K)
- K160123Apinator2Cleared 510(K)
- K153291SICAT OPTISLEEP2Cleared 510(K)
- K150566Oniris2Cleared 510(K)
- K160234OVENT2Cleared 510(K)
- K152292Respire Blue Series-EF2Cleared 510(K)
- K152159Oravan Herbst2Cleared 510(K)
- K150572Respire Pink Series-Herbst-EF2Cleared 510(K)
- K142651The Moses Express appliance2Cleared 510(K)
- K150941Somnowell Mandibular Advancement Appliance (MAA)2Cleared 510(K)
- K143591Dorsal Appliance2Cleared 510(K)
- K143244The Panthera Anti-Snoring Device2Cleared 510(K)
- K140663THERASNORE2Cleared 510(K)
- K133390NDX DORSAL APPLIANCE2Cleared 510(K)
- K140429CRANE ACRYLIC HERBST APPLIANCE2Cleared 510(K)
- K140777ZQUIET-SA2Cleared 510(K)
- K133683MICR02 OSA DEVICE2Cleared 510(K)
- K140435MEDLEY GOLD2Cleared 510(K)
- K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX2Cleared 510(K)
- K132506SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY2Cleared 510(K)
- K130067MRNA APPLIANCE2Cleared 510(K)
- K132933THE MOSES ELITE APPLIANCE2Cleared 510(K)
- K130797LUCO HYBRID OSA APPLIANCE2Cleared 510(K)
- K130504ASA ORAL APPLIANCES2Cleared 510(K)
- K131138RESPIRE PINK SERIES - HERBST2Cleared 510(K)
- K113126ACRYLIC HERBST APPLIANCE2Cleared 510(K)
- K130558SOMNODENT HERBST; CLASSIC, FLEX2Cleared 510(K)
- K123410HEALTHY SLEEP APPLIANCE2Cleared 510(K)
- K121285ORAVAN OSA2Cleared 510(K)
- K122391MEDTRONIC XOMED, INC.2Cleared 510(K)
- K113516THERASOM-CAST2Cleared 510(K)
- K122475ZQUIET PRO-PLUS2Cleared 510(K)
- K121344NU SLEEP2Cleared 510(K)
- K121761SOMNOGUARD SP SOFT2Cleared 510(K)
- K120372DR GREENBURGS HYBRID VACUUM2Cleared 510(K)
- K120371DR GREENBURGS HYBRID ACRYLIC2Cleared 510(K)
- K113022PURESLEEP2Cleared 510(K)
- K121340SOMNODENT G22Cleared 510(K)
- K103704REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP2Cleared 510(K)
- K113569APNEARX2Cleared 510(K)
- K110623PILLAR PALATAL IMPLANT SYSTEM2Cleared 510(K)
- K111680DR. GREENSBURG'S HYBRID2Cleared 510(K)
- K112205SNORERX 9.02Cleared 510(K)
- K111207RESPIRE BLUE SERIES2Cleared 510(K)
- K111110APNEA GUARD2Cleared 510(K)
- K111009ACRYLIC HERBST APPLIANCE2Cleared 510(K)
- K102463GOOD NIGHT2Cleared 510(K)
- K101155AURADORM (NEUROMUSCULAR SLEEP)2Cleared 510(K)
- K102521PANTINO PRO POSITINER2Cleared 510(K)
- K103004SNORE GUARD2Cleared 510(K)
- K103076DYNAFLEX2Cleared 510(K)
- K100185SLEEP APP2Cleared 510(K)
- K102118SNORE GUARD ADVANCE2Cleared 510(K)
- K101709LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)2Cleared 510(K)
- K093407ZQUIET MOUTHPIECE2Cleared 510(K)
- K093340PASR/QUIETNITE2Cleared 510(K)
- K093710THE MOSES APPLIANCE2Cleared 510(K)
- K090436AIRWAYEASE MAS2Cleared 510(K)
- K092942VITAL SLEEP2Cleared 510(K)
- K082849SILENT SLEEP2Cleared 510(K)
- K090503ZQUIET MOUTHPIECE2Cleared 510(K)
- K083209ACRYLIC HERBST SPLINT APPLIANCE2Cleared 510(K)
- K081965MPOWRX SNORING SOLUTION2Cleared 510(K)
- K072731ENDSNOR2Cleared 510(K)
- K073004SOMNOMED BFLEX2Cleared 510(K)
- K070327REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR2Cleared 510(K)
- K060795SOMNOFIT2Cleared 510(K)
- K062333LAIMAD2Cleared 510(K)
- K062951TAP III ANTI-SNORING DEVICE2Cleared 510(K)
- K061688ANTI-SNORING / SLEEP APNEA DEVICE2Cleared 510(K)
- K061732TAP-T2Cleared 510(K)
- K060744O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)2Cleared 510(K)
- K060122SLEEP SPLINT2Cleared 510(K)
- K060388TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT2Cleared 510(K)
- K051014SILENT PARTNER SERIES OSA APPLIANCES2Cleared 510(K)
- K050592SOMNOMED MAS RXA2Cleared 510(K)
- K041184NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION2Cleared 510(K)
- K042161ANTI-SNORING/SLEEP APNEA DEVICE2Cleared 510(K)
- K040417PILLAR PALATAL IMPLANT SYSTEM2Cleared 510(K)
- K021569RESTFUL NIGHTS, IST-APPLIANCE2Cleared 510(K)
- K033823RESPIRONICS CUSTOM II ORAL APPLIANCE2Cleared 510(K)
- K033822RESPIRONICS CUSTOM I ORAL APPLIANCE2Cleared 510(K)
- K030440OASYS-ORAL AIRWAY SYSTEM2Cleared 510(K)
- K023836THE SUAD DEVICE2Cleared 510(K)
- K022891THE BREATHE EZ ANTI-SNORING DEVICE2Cleared 510(K)
- K011723ANTI-SNORING DEVICE OR ASD2Cleared 510(K)
- K022284SNORE-AID MAX2Cleared 510(K)
- K020893NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE2Cleared 510(K)
- K013687NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER2Cleared 510(K)
- K013808SLEEPBITE2Cleared 510(K)
- K013049NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE2Cleared 510(K)
- K012142THE QUIET SLEEPER2Cleared 510(K)
- K993381TONGUE STABILIZER DEVICE2Cleared 510(K)
- K991209ORAL SLEEP DISORDER AID2Cleared 510(K)
- K991948DR. B'S MOUTHPIECE, MODEL 32129-100022Cleared 510(K)
- K981677REPOSE BONE SCREW SYSTEM2Cleared 510(K)
- K991449SNORE-AID PLUS2Cleared 510(K)
- K981923THE SNORE PEACE2Cleared 510(K)
- K980952SNORE-CURE ANTI-SNORING APPLIANCE2Cleared 510(K)
- K974531SNORE-EZZER2Cleared 510(K)
- K973884ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE2Cleared 510(K)
- K963591SNORING CONTROL DEVICE2Cleared 510(K)
- K973038ADJUSTABLE THERASNORE2Cleared 510(K)
- K971794ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE2Cleared 510(K)
- K972424SILENTNITE2Cleared 510(K)
- K972023SLEEP-IN BONE SCREW SYSTEM2Cleared 510(K)
- K972061TOA2Cleared 510(K)
- K963063SNORE TEC2Cleared 510(K)
- K964516TAP2Cleared 510(K)
- K962516TAP ANTI-SNORING DEVICE2Cleared 510(K)
- K955822REMOVABLE HERBST APPLIANCE2Cleared 510(K)
- K955336SNOREFREE2Cleared 510(K)
- K954530THE SILENCER2Cleared 510(K)
- K954324SNOR-X MOUTH GUARD2Cleared 510(K)
- K954128SNOREMASTER2Cleared 510(K)
- K950763LOWE KLEARWAY2Cleared 510(K)
- K926382THERASNORE2Cleared 510(K)
- K922984ORTHODONTIC BITE2Cleared 510(K)
- K895189ADJUSTABLE SOFT PALATE LIFTER2Cleared 510(K)
- K882303H&M ANTI-SNORING DEVICE2Cleared 510(K)
- K874416DENTAL ANTI-SNORING DEVICE2Cleared 510(K)
- LTFStimulator, Salivary System2Product Code
- MEFRing, Teething, Non-Fluid Filled1Product Code
- NJMBracket, Ceramic, Orthodontic2Product Code
- NLCBracket, Plastic, Orthodontic, Reprocessed2Product Code
- NQSBracket, Metal, Orthodontic, Reprocessed1Product Code
- NTORinse, Oral, Antibacterial (By Physical Means)2Product Code
- NXCAligner, Sequential2Product Code
- PLCSleep Appliances With Patient Monitoring2Product Code
- OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea2Product Code
- ORYPrelude Tongue Suspension System2Product Code
- OYHOrthodontic Vibratory Accessory2Product Code
- PLHOrthodontic Led Accessory2Product Code
- PNNOrthodontic Software2Product Code
- QCJClosed Loop Auto Titration Device For Oral Appliances2Product Code
- QJJIndirect Bonding Tray1Product Code
- QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea2Product Code
- QTTOver The Counter Electrical Salivary Stimulatory System2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PureSleep (OTC use)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K190058
- 510(k) Type
- Traditional
- Applicant
- Sleep Science Partners, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/11/2019
- Days to Decision
- 90 days
- Submission Type
- Summary