510(k) Report

Devices descending from K981445

55 later devices reach Ultima Airflow Sensor, 0510 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080922Salter Labs Oral/Nasal Thermal Airflow SensorSalter Labs, Division of Regulatory Affairs200831
+1K984431Ultima Airflow Pressure SensorBraebon Medical Corp.199850—
+2K161953ReDe MaskTereopneuma20170—
+2K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor…Salter Labs20160—
+2K092685Pneumotherml, Model: 5800Salter Labs20090—
+2K080983Provent Nasal CannulaVentus Medical, Inc.200801
+2K061764Medibyte, Model MP8Braebon Medical Corp.20060—
+2K031202Medipalm-20Braebon Medical Corp.200348—
+3K073682Embletta GoldEmbla Systems, Inc.2008411
+3K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A.20084—
+4K171384Micromed BRAIN QUICK systemMicromed S.P.A.201801
+4K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC20133—
+4K122516Embletta MPREmbla Systems2013271
+4K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+4K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+5K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+5K203343Wesper LabWesper, Inc.20211—
+5K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+5K161579Watch-PAT200UItamar Medical, Ltd.201720—
+5K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+5K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+5K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+5K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+6K260050WRAP SystemHuneo, LLC20260—
+6K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+6K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+6K221816Wesper LabWesper, Inc.20230—
+6K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+6K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+6K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+6K191031NightOwlEctosense NV20205—
+6K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+6K180775Watch-PAT300Itamar Medical, Ltd.201812—
+7K252628CassieWesper, Inc.20260—
+7K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+7K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+7K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+7K231355AuroraEnsodata20240—
+7K231546SomfitCompumedics Limited20231—
+7K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+7K213463NightOwlEctosense NV20213—
+7K183559WatchPAT ONEItamar Medical, Ltd.20195—
+8K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+8K252383Somfit DCompumedics Limited20250—
+8K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+8K220095ANNE SleepSibel, Inc.20224—
+8K220028NightOwlEctosense NV20222—
+9K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+9K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+9K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+9K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+10K254042WatchPAT SWItamar Medical, Ltd.20260—
+10K244027Sansa HsatHuxley Medical20252—
+11K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+11K252497Sansa HsatHuxley Medical20250—