| WatchPAT SW (K254042) | Itamar Medical , Ltd. | 2026-07-31 |
| WRAP System (K260050) | Huneo, LLC | 2026-07-15 |
| RX-1 Sleep (K253148) | Vivaquant, Inc. Dba Rhythm Express | 2026-06-22 |
| CASSIE (K252628) | Wesper, Inc. | 2026-04-27 |
| SANSA HSAT (K252497) | Huxley Medical | 2025-12-10 |
| SANSA HSAT (K250882) | Huxley Medical | 2025-10-29 |
| WatchPAT400 (WP400) (K250460) | Itamar Medical , Ltd. | 2025-09-05 |
| Somfit D (K252383) | Compumedics Limited | 2025-08-28 |
| Onera STS 2 (ONERA STS 2) (K243220) | Onera B.V. | 2025-07-03 |
| Happy Health Home Sleep Test (K242224) | Happy Health, Inc. | 2025-06-18 |
| AcuPebble Ox (200) (K243092) | Acurable Limited | 2025-03-19 |
| TipTraQ (TTQ001) (K243268) | Pranaq Pte. , Ltd. | 2025-02-03 |
| SANSA HSAT (K244027) | Huxley Medical | 2025-01-28 |
| DormoTech NLab (K242290) | Dormotech Medical, Ltd. | 2025-01-08 |
| Bluebird Single-Use Respiratory Effort Belt (K242424) | Cadwell Industries, Inc. | 2024-12-18 |
| Withings Sleep Rx (K231667) | Withings | 2024-09-06 |
| “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) (K233501) | Largan Medical Co., Ltd. | 2024-07-26 |
| Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285) | Huxley Medical | 2024-07-15 |
| SAM Model 9-10000 (K240100) | Snap Diagnostics, LLC | 2024-06-04 |
| Aurora (K231355) | Ensodata | 2024-02-09 |
| Somfit (K231546) | Compumedics Limited | 2023-11-30 |
| Onera Sleep Test System (Onera STS) (K223573) | Onera B.V. | 2023-08-18 |
| Wesper Lab (K221816) | Wesper, Inc. | 2023-03-09 |
| Belun Sleep System BLS-100 (K222579) | Belun Technology Company Limited | 2023-02-23 |
| AcuPebble OX100 (K222950) | Acurable Limited | 2023-02-03 |
| WatchPAT ONE (WP1) (K223675) | Itamar Medical , Ltd. | 2023-01-06 |
| BresoDX1 (K220012) | Bresotec, Inc. | 2022-12-21 |
| WatchPAT300 (WP300) (K222331) | Itamar Medical , Ltd. | 2022-09-14 |
| ANNE Sleep (K220095) | Sibel, Inc. | 2022-07-11 |
| SleepCheckRx (K213360) | Resapp Health | 2022-07-05 |
| Onera Sleep Test System (Onera STS) (K210593) | Onera B.V. | 2022-04-06 |
| WatchPAT200U (WP200U) (K203839) | Itamar Medical , Ltd. | 2022-03-21 |
| NightOwl (K220028) | Ectosense NV | 2022-02-24 |
| Wesper Lab (K203343) | Wesper, Inc. | 2021-12-21 |
| NightOwl (K213463) | Ectosense NV | 2021-12-16 |
| AcuPebble SA (K210480) | Acurable Limited | 2021-07-06 |
| Maxxi Flow Sensor (K201495) | Neurovirtual USA, Inc. | 2020-12-14 |
| MATRx plus (K200695) | Zephyr Sleep Technologies | 2020-08-24 |
| Rubicon SA System (K200654) | Dymedix Diagnostics, Inc. | 2020-07-22 |
| NightOwl (K191031) | Ectosense NV | 2020-03-06 |
| Maxxi Snore Sensor (K191095) | Neurovirtual USA, Inc. | 2020-01-16 |
| MATRx Plus (K191925) | Zephyr Sleep Technologies | 2019-10-29 |
| SomnaPatch (K183625) | Respironics, Inc. | 2019-10-18 |
| Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant (K180001) | Embla Systems | 2019-09-27 |
| SleepImage System (K182618) | Mycardio, LLC Dba Sleepimage. | 2019-08-14 |
| DROWZLE (K173974) | Resonea, Inc. | 2019-07-14 |
| Maxxi Rip Sensor (K171304) | Neurovirtual USA, Inc. | 2019-06-24 |
| WatchPAT ONE (K183559) | Itamar Medical , Ltd. | 2019-06-05 |
| XactTrace Single Use Respiratory Effort Belt System (K173793) | Embla Systems | 2019-03-01 |
| MATRx Plus (K181996) | Zephyr Sleep Technologies | 2018-11-21 |
| Watch-PAT300 (K180775) | Itamar Medical , Ltd. | 2018-08-17 |
| Positional Sleep Assessment System (PoSAS) software (K172799) | Advanced Brain Monitoring | 2018-03-09 |
| SleepImage System (K163696) | Mycardio, LLC Dba Sleepimage. | 2017-10-13 |
| MATRx plus (K163665) | Zephyr Sleep Technologies | 2017-05-05 |
| Apnea Risk Evaluation System (ARES), Model 620 (K160499) | Watermark Medical | 2017-04-24 |
| Watch-PAT200U (K161579) | Itamar Medical , Ltd. | 2017-02-24 |
| Watch-PAT200U (K153070) | Itamar Medical , Ltd. | 2016-07-26 |
| BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal (K151874) | Salter Labs | 2016-04-15 |
| AUDICOR CA300/CC100 Analyzer with SDB (K151433) | Inovise Medical, Inc. | 2016-03-18 |
| Nox RIP Belts & Cables (K151361) | Nox Medical Ehf | 2015-11-06 |
| SnoreSounds (K150102) | Appian Medical, Inc. | 2015-11-05 |
| ApneaLink Air (K143272) | Resmed Germany, Inc. | 2015-04-30 |
| SOMNOTOUCH RESP (K140861) | Somnomedics GmbH | 2015-01-30 |
| WATCH-PAT200U (WP200U) (K133859) | Itamar Medical , Ltd. | 2014-05-30 |
| AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) (K131883) | Inovise Medical, Inc. | 2014-04-11 |
| APNEALINK PRO (K131932) | Resmed Germany, Inc. | 2013-11-08 |
| SOMNOLYZER 24X7 (K131994) | Respironics, Inc. | 2013-10-17 |
| QDC-PRO, AND NOX-RIP (K124062) | Nox Medical | 2013-07-10 |
| EMBLETTA MPR (K122516) | Embla Systems | 2013-02-21 |
| APNEA RISK EVALUATION SYSTEM (ARES) (K112514) | Advanced Brain Monitoring, Inc. | 2012-01-09 |
| SLEEPSTRIP II (K112822) | S.L.P. , Ltd. | 2011-12-27 |
| MICHELE SLEEP SCORING SYSTEMS (K112102) | Younes Sleep Technologies | 2011-12-20 |
| MORPHEUS OX (K111314) | Widemed, Ltd. | 2011-08-31 |
| MDRIVE (K111742) | Embla Systems | 2011-08-31 |
| ACCUSOM (K110486) | Novasom, Inc. | 2011-08-12 |
| APNEA RISK EVALUATION SYSTEM (ARES) (K111194) | Advanced Brain Monitoring, Inc. | 2011-07-07 |
| WATCH-PAT 200S-3 (WP200S-3) (K102567) | Itamar Medical , Ltd. | 2011-06-02 |
| APNEA RISK EVALUATION SYSTEM (ARES) (K110705) | Advanced Brain Monitoring, Inc. | 2011-04-14 |
| SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM (K110064) | Snap Diagnostics, LLC | 2011-03-18 |
| CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE (K092003) | MyCardio, LLC | 2009-09-30 |
| ALICE PDX (K090484) | Respironics Inc., Sleep & Home Respiratory Group | 2009-06-26 |
| INOMAX DS (DELIVERY SYSTEM) (K090958) | Ino Therapeutics, LLC | 2009-06-18 |
| CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR (K082853) | Inspired Technologies, Inc. | 2009-03-23 |
| APNEALINK PLUS, MODEL: 22328 (K083575) | Resmed Germany, Inc. | 2009-03-19 |
| SOMNOLYZER 24X7 (K083620) | The Siesta Group North America | 2009-03-06 |
| GALAXY (K083874) | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-26 |
| APNEICARE CONNECTION CENTER/INTERNET ANALYSIS (K082968) | Apneicare, LLC | 2009-01-02 |
| HOLTER LX ANALYSIS (K081861) | North East Monitoring, Inc. | 2008-12-04 |
| NOX T3, NOXTURNAL (PC APPLICATION) (K082113) | Nox Medical | 2008-11-07 |
| SOMNOWATCH (K081485) | Somnomedics GmbH | 2008-09-18 |
| RMX PHYSIOLOGICAL DATA RECORDER (K080375) | S.L.P. , Ltd. | 2008-09-02 |
| WATCH-PAT 200S-2 (WP200S-2) (K081982) | Itamar Medical | 2008-08-14 |
| EMBLETTA GOLD (K073682) | Embla Systems, Inc. | 2008-08-08 |
| PROVENT NASAL CANNULA (K080983) | Ventus Medical, Inc. | 2008-08-07 |
| FLOCHANNEL (K081176) | Chad Therapeutics, Inc. | 2008-07-28 |
| WATCH-PAT 200I (WP200I) (K081037) | Itamar Medical | 2008-06-09 |
| WATCH-PAT MODEL 100S-2 (K080427) | Itamar Medical | 2008-05-23 |
| SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM (K080321) | Snap Laboratories, LLC | 2008-05-23 |
| HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM (K073269) | Hypnocore, Ltd. | 2008-04-18 |
| COMPUMEDICS SOMTE PSG RECORDING SYSTEM (K072201) | Compumedics Limited | 2008-04-14 |