Product Code: MNR FDA class 2 21 CFR 868.2375

Ventilatory Effort Recorder

Anesthesiology

The Ventilatory Effort Recorder is an anesthesiology device used to monitor and record the breathing efforts of patients, providing clinicians with data on respiratory muscle activity and ventilatory patterns. Classified as FDA Class 2 under 21 CFR 868.2375 in the Anesthesiology specialty, it requires 510(k) premarket notification. The product code is MNR, and it is eligible for third-party 510(k) review.

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510(k)s

161

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MNR
Device Class: FDA class 2
Regulation Number: 868.2375
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 161 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252628	CASSIE	Apr 27, 2026	Substantially Equivalent	Wesper, Inc.
K252497	SANSA HSAT	Dec 10, 2025	Substantially Equivalent	Huxley Medical
K250882	SANSA HSAT	Oct 29, 2025	Substantially Equivalent	Huxley Medical
K250460	WatchPAT400 (WP400)	Sep 05, 2025	Substantially Equivalent	Itamar Medical , Ltd.
K252383	Somfit D	Aug 28, 2025	Substantially Equivalent	Compumedics Limited
K243220	Onera STS 2 (ONERA STS 2)	Jul 03, 2025	Substantially Equivalent	Onera B.V.
K242224	Happy Health Home Sleep Test	Jun 18, 2025	Substantially Equivalent	Happy Health, Inc.
K243092	AcuPebble Ox (200)	Mar 19, 2025	Substantially Equivalent	Acurable Limited
K243268	TipTraQ (TTQ001)	Feb 03, 2025	Substantially Equivalent	Pranaq Pte. , Ltd.
K244027	SANSA HSAT	Jan 28, 2025	Substantially Equivalent	Huxley Medical
K242290	DormoTech NLab	Jan 08, 2025	Substantially Equivalent	Dormotech Medical, Ltd.
K242424	Bluebird Single-Use Respiratory Effort Belt	Dec 18, 2024	Substantially Equivalent	Cadwell Industries, Inc.
K231667	Withings Sleep Rx	Sep 06, 2024	Substantially Equivalent	Withings
K233501	LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)	Jul 26, 2024	Substantially Equivalent	Largan Medical Co., Ltd.
K240285	Huxley SANSA Home Sleep Apnea Test (1000-00)	Jul 15, 2024	Substantially Equivalent	Huxley Medical
K240100	SAM Model 9-10000	Jun 04, 2024	Substantially Equivalent	Snap Diagnostics, LLC
K231355	Aurora	Feb 09, 2024	Substantially Equivalent	Ensodata
K231546	Somfit	Nov 30, 2023	Substantially Equivalent	Compumedics Limited
K223573	Onera Sleep Test System (Onera STS)	Aug 18, 2023	Substantially Equivalent	Onera B.V.
K221816	Wesper Lab	Mar 09, 2023	Substantially Equivalent	Wesper, Inc.
K222579	Belun Sleep System BLS-100	Feb 23, 2023	Substantially Equivalent	Belun Technology Company Limited
K222950	AcuPebble OX100	Feb 03, 2023	Substantially Equivalent	Acurable Limited
K223675	WatchPAT ONE (WP1)	Jan 06, 2023	Substantially Equivalent	Itamar Medical , Ltd.
K220012	BresoDX1	Dec 21, 2022	Substantially Equivalent	Bresotec, Inc.
K222331	WatchPAT300 (WP300)	Sep 14, 2022	Substantially Equivalent	Itamar Medical , Ltd.
K220095	ANNE Sleep	Jul 11, 2022	Substantially Equivalent	Sibel, Inc.
K213360	SleepCheckRx	Jul 05, 2022	Substantially Equivalent	Resapp Health
K210593	Onera Sleep Test System (Onera STS)	Apr 06, 2022	Substantially Equivalent	Onera B.V.
K203839	WatchPAT200U (WP200U)	Mar 21, 2022	Substantially Equivalent	Itamar Medical , Ltd.
K220028	NightOwl	Feb 24, 2022	Substantially Equivalent	Ectosense NV
K203343	Wesper Lab	Dec 21, 2021	Substantially Equivalent	Wesper, Inc.
K213463	NightOwl	Dec 16, 2021	Substantially Equivalent	Ectosense NV
K210480	AcuPebble SA	Jul 06, 2021	Substantially Equivalent	Acurable Limited
K201495	Maxxi Flow Sensor	Dec 14, 2020	Substantially Equivalent	Neurovirtual USA, Inc.
K200695	MATRx plus	Aug 24, 2020	Substantially Equivalent	Zephyr Sleep Technologies
K200654	Rubicon SA System	Jul 22, 2020	Substantially Equivalent	Dymedix Diagnostics, Inc.
K191031	NightOwl	Mar 06, 2020	Substantially Equivalent	Ectosense NV
K191095	Maxxi Snore Sensor	Jan 16, 2020	Substantially Equivalent	Neurovirtual USA, Inc.
K191925	MATRx Plus	Oct 29, 2019	Substantially Equivalent	Zephyr Sleep Technologies
K183625	SomnaPatch	Oct 18, 2019	Substantially Equivalent	Respironics, Inc.
K180001	Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant	Sep 27, 2019	Substantially Equivalent	Embla Systems
K182618	SleepImage System	Aug 14, 2019	Substantially Equivalent	Mycardio, LLC Dba Sleepimage.
K173974	DROWZLE	Jul 14, 2019	Substantially Equivalent	Resonea, Inc.
K171304	Maxxi Rip Sensor	Jun 24, 2019	Substantially Equivalent	Neurovirtual USA, Inc.
K183559	WatchPAT ONE	Jun 05, 2019	Substantially Equivalent	Itamar Medical , Ltd.
K173793	XactTrace Single Use Respiratory Effort Belt System	Mar 01, 2019	Substantially Equivalent	Embla Systems
K181996	MATRx Plus	Nov 21, 2018	Substantially Equivalent	Zephyr Sleep Technologies
K180775	Watch-PAT300	Aug 17, 2018	Substantially Equivalent	Itamar Medical , Ltd.
K172799	Positional Sleep Assessment System (PoSAS) software	Mar 09, 2018	Substantially Equivalent	Advanced Brain Monitoring
K163696	SleepImage System	Oct 13, 2017	Substantially Equivalent	Mycardio, LLC Dba Sleepimage.
K163665	MATRx plus	May 05, 2017	Substantially Equivalent	Zephyr Sleep Technologies
K160499	Apnea Risk Evaluation System (ARES), Model 620	Apr 24, 2017	Substantially Equivalent	Watermark Medical
K161579	Watch-PAT200U	Feb 24, 2017	Substantially Equivalent	Itamar Medical , Ltd.
K153070	Watch-PAT200U	Jul 26, 2016	Substantially Equivalent	Itamar Medical , Ltd.
K151874	BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal	Apr 15, 2016	Substantially Equivalent	Salter Labs
K151433	AUDICOR CA300/CC100 Analyzer with SDB	Mar 18, 2016	Substantially Equivalent	Inovise Medical, Inc.
K151361	Nox RIP Belts & Cables	Nov 06, 2015	Substantially Equivalent	Nox Medical Ehf
K150102	SnoreSounds	Nov 05, 2015	Substantially Equivalent	Appian Medical, Inc.
K143272	ApneaLink Air	Apr 30, 2015	Substantially Equivalent	Resmed Germany, Inc.
K140861	SOMNOTOUCH RESP	Jan 30, 2015	Substantially Equivalent	Somnomedics GmbH
K133859	WATCH-PAT200U (WP200U)	May 30, 2014	Substantially Equivalent	Itamar Medical , Ltd.
K131883	AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)	Apr 11, 2014	Substantially Equivalent	Inovise Medical, Inc.
K131932	APNEALINK PRO	Nov 08, 2013	Substantially Equivalent	Resmed Germany, Inc.
K131994	SOMNOLYZER 24X7	Oct 17, 2013	Substantially Equivalent	Respironics, Inc.
K124062	QDC-PRO, AND NOX-RIP	Jul 10, 2013	Substantially Equivalent	Nox Medical
K122516	EMBLETTA MPR	Feb 21, 2013	Substantially Equivalent	Embla Systems
K112514	APNEA RISK EVALUATION SYSTEM (ARES)	Jan 09, 2012	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K112822	SLEEPSTRIP II	Dec 27, 2011	Substantially Equivalent	S.L.P. , Ltd.
K112102	MICHELE SLEEP SCORING SYSTEMS	Dec 20, 2011	Substantially Equivalent	Younes Sleep Technologies
K111742	MDRIVE	Aug 31, 2011	Substantially Equivalent	Embla Systems
K111314	MORPHEUS OX	Aug 31, 2011	Substantially Equivalent	Widemed, Ltd.
K110486	ACCUSOM	Aug 12, 2011	Substantially Equivalent	Novasom, Inc.
K111194	APNEA RISK EVALUATION SYSTEM (ARES)	Jul 07, 2011	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K102567	WATCH-PAT 200S-3 (WP200S-3)	Jun 02, 2011	Substantially Equivalent	Itamar Medical , Ltd.
K110705	APNEA RISK EVALUATION SYSTEM (ARES)	Apr 14, 2011	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K110064	SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM	Mar 18, 2011	Substantially Equivalent	Snap Diagnostics, LLC
K092003	CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE	Sep 30, 2009	Substantially Equivalent	MyCardio, LLC
K090484	ALICE PDX	Jun 26, 2009	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group
K090958	INOMAX DS (DELIVERY SYSTEM)	Jun 18, 2009	Substantially Equivalent	Ino Therapeutics, LLC
K082853	CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR	Mar 23, 2009	Substantially Equivalent	Inspired Technologies, Inc.
K083575	APNEALINK PLUS, MODEL: 22328	Mar 19, 2009	Substantially Equivalent	Resmed Germany, Inc.
K083620	SOMNOLYZER 24X7	Mar 06, 2009	Substantially Equivalent	The Siesta Group North America
K083874	GALAXY	Jan 26, 2009	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group
K082968	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	Jan 02, 2009	Substantially Equivalent	Apneicare, LLC
K081861	HOLTER LX ANALYSIS	Dec 04, 2008	Substantially Equivalent	North East Monitoring, Inc.
K082113	NOX T3, NOXTURNAL (PC APPLICATION)	Nov 07, 2008	Substantially Equivalent	Nox Medical
K081485	SOMNOWATCH	Sep 18, 2008	Substantially Equivalent	Somnomedics GmbH
K080375	RMX PHYSIOLOGICAL DATA RECORDER	Sep 02, 2008	Substantially Equivalent	S.L.P. , Ltd.
K081982	WATCH-PAT 200S-2 (WP200S-2)	Aug 14, 2008	Substantially Equivalent	Itamar Medical
K073682	EMBLETTA GOLD	Aug 08, 2008	Substantially Equivalent	Embla Systems, Inc.
K080983	PROVENT NASAL CANNULA	Aug 07, 2008	Substantially Equivalent	Ventus Medical, Inc.
K081176	FLOCHANNEL	Jul 28, 2008	Substantially Equivalent	Chad Therapeutics, Inc.
K081037	WATCH-PAT 200I (WP200I)	Jun 09, 2008	Substantially Equivalent	Itamar Medical
K080427	WATCH-PAT MODEL 100S-2	May 23, 2008	Substantially Equivalent	Itamar Medical
K080321	SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM	May 23, 2008	Substantially Equivalent	Snap Laboratories, LLC
K073269	HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM	Apr 18, 2008	Substantially Equivalent	Hypnocore, Ltd.
K072201	COMPUMEDICS SOMTE PSG RECORDING SYSTEM	Apr 14, 2008	Substantially Equivalent	Compumedics Limited
K070855	SLEEP QUALITY	Mar 20, 2008	Substantially Equivalent	Dynadx Corporation
K072014	VITASCORE	Nov 08, 2007	Substantially Equivalent	Vitascore B.V.
K071230	APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600	Oct 03, 2007	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K071556	SOMNOSCREEN EEG10-20	Jul 18, 2007	Substantially Equivalent	Somnomedics GmbH
K070263	APNEALINK	Jun 15, 2007	Substantially Equivalent	Resmed Germany, Inc.
K070326	NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM	May 05, 2007	Substantially Equivalent	Widemed, Ltd.
K060708	SOMNOSCREEN	Jan 24, 2007	Substantially Equivalent	Somnomedics GmbH & Co. KG
K061705	CADWELL EASYNET NASAL PRESSURE MODULE	Nov 21, 2006	Substantially Equivalent	Cadwell Laboratories, Inc.
K061996	SANDMAN POCKET	Oct 03, 2006	Substantially Equivalent	Eb Neuro S.P.A.
K061764	MEDIBYTE, MODEL MP8	Sep 06, 2006	Substantially Equivalent	Braebon Medical Corp.
K061405	APNEALINK, MODEL 22302	Jul 25, 2006	Substantially Equivalent	Resmed Germany, Inc.
K052573	STARDUST II	Dec 13, 2005	Substantially Equivalent	Respironics, Inc.
K051313	BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER	Sep 15, 2005	Substantially Equivalent	Salter Labs
K042745	LIFESCREEN APNEA	Jan 19, 2005	Substantially Equivalent	Del Mar Reynolds Medical, Inc.
K042916	WATCH PAT 100S	Dec 29, 2004	Substantially Equivalent	Itamar Medical
K043132	UNIVERSAL XACTTRACE	Dec 21, 2004	Substantially Equivalent	Medcare Flaga
K041662	APNEA RISK EVALUATION SYSTEM (ARES)	Oct 14, 2004	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K042253	SLEEPSENSE SLEEP SENSORS	Oct 06, 2004	Substantially Equivalent	S.L.P. , Ltd.
K041724	COMPASS M10 SYSTEM	Sep 28, 2004	Substantially Equivalent	Medcare Flaga
K041904	COMPASS F10 SYSTEM	Sep 07, 2004	Substantially Equivalent	Medcare Flaga
K040576	MICROMESAM BASIC-SET	Jul 01, 2004	Substantially Equivalent	Map Medizintechnik Fur Arzt Und Patient GmbH
K033402	PORTABLE SLEEP DATA RECORDER (PSDR)	Jun 30, 2004	Substantially Equivalent	Pro-Tech Services, Inc.
K021845	STARDUST II, MODEL 1011176	May 20, 2004	Substantially Equivalent	Respironics, Inc.
K040069	DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR	May 05, 2004	Substantially Equivalent	Dymedix, Inc.
K040194	COMPUMEDICS SUMMIT IP	Apr 23, 2004	Substantially Equivalent	Compumedics USA, Ltd.
K024322	EMBLA N7000	Oct 27, 2003	Substantially Equivalent	Medcare Flaga
K030379	APLAB, MODEL 801D0030	Aug 29, 2003	Substantially Equivalent	Sector Medical Corp.
K022506	MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM	May 15, 2003	Substantially Equivalent	Widemed, Ltd.
K022294	APNEACHECK	Apr 25, 2003	Substantially Equivalent	Im Systems
K030611	MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM	Mar 24, 2003	Substantially Equivalent	Nellcor Puritan Bennett (Melville) , Ltd.
K021138	SLEEPSCREEN/APNOESCREEN CARDIO	Feb 12, 2003	Substantially Equivalent	Erich Jaeger GmbH
K021176	COMPUMEDICS SOMTE SYSTEM	Jan 21, 2003	Substantially Equivalent	Compumedics Limited
K020607	SLEEPFLO, MODEL 101501	Aug 30, 2002	Substantially Equivalent	Biomec, Inc.
K020312	ULTIMA SNORING MIKE, MODEL 0540	Aug 07, 2002	Substantially Equivalent	Braebon Medical Corp.
K012437	DEVILBISS SLEEP RECORDER MODEL # RM60	Jul 16, 2002	Substantially Equivalent	Sunrise Medical Hhg, Inc.
K002159	SNORE SAT RECORDER, MODEL SS41	Jun 28, 2002	Substantially Equivalent	Sagatech Electronics, Inc.
K010156	SLEEP PAT 200 DEVICE	Jun 19, 2002	Substantially Equivalent	Itamar Medical (C.M.) 1997 , Ltd.
K013905	MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS	Apr 22, 2002	Substantially Equivalent	Pro-Tech Services, Inc.
K010739	WATCH-PAT 100	Nov 06, 2001	Substantially Equivalent	Itamar Medical (C.M.) 1997 , Ltd.
K002095	SNAP MODEL 6	Mar 02, 2001	Substantially Equivalent	Snap Laboratories, LLC
K000396	APNOESCREEN PRO, ALPHA SCREEN PRO	Dec 27, 2000	Substantially Equivalent	Erich Jaeger, Inc.
K002135	SLEEPSTRIP DISPOSABLE APNEA SCREENER	Dec 06, 2000	Substantially Equivalent	Influent , Ltd.
K000253	SILENT NIGHT V	Nov 16, 2000	Substantially Equivalent	Sleep Solutions, Inc.
K992322	SNAP MODEL 5	Feb 02, 2000	Substantially Equivalent	Snap Laboratories, LLC
K990565	SUZANNE	Aug 18, 1999	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K990321	ALPHAMED GEMINI SENSOR, SNORING SENSOR	Jun 01, 1999	Substantially Equivalent	Alphamed, Inc.
K984169	DIGI-SNAP	May 26, 1999	Substantially Equivalent	Snap Laboratories, LLC
K990199	SMARTRECORDER, MODEL 2500	Apr 19, 1999	Substantially Equivalent	Respironics, Inc.
K983572	SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500	Mar 19, 1999	Substantially Equivalent	Healthdyne Technologies, Inc.
K981034	SILENT NIGHT II	Oct 30, 1998	Substantially Equivalent	Sleep Solutions, Inc.
K982293	PRESSURE TRANSDUCER AIRFLOW SENSOR	Jul 13, 1998	Substantially Equivalent	Pro-Tech Services, Inc.
K973920	STARDUST	May 14, 1998	Substantially Equivalent	Respironics, Inc.
K971803	NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101	Nov 12, 1997	Substantially Equivalent	Neurotronics, Inc.
K971501	SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER	Oct 14, 1997	Substantially Equivalent	Bio-Logic Systems Corp.
K971184	OXI-SNAP	Oct 01, 1997	Substantially Equivalent	Snap Laboratories, LLC
K955841	SLEEP SYSTEM FOR CLINICS & RESEARCH	Mar 11, 1997	Unknown	Compumedics Ptd , Ltd.
K964494	SLEEPWIZARD	Feb 04, 1997	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K963597	SILENT NIGHT I	Jan 23, 1997	Substantially Equivalent	Local Silence, Inc.
K962103	BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER	Aug 22, 1996	Substantially Equivalent	Bio-Logic Systems Corp.
K944524	SNAP TESTING DEVICE	Oct 26, 1995	Substantially Equivalent	Snap Laboratories, LLC
K950273	SLEEP TEST(TM)	Sep 19, 1995	Substantially Equivalent	Cns, Inc.
K940013	BODY POSITION INDICATOR, MODEL BPI1	May 04, 1995	Substantially Equivalent	Pro-Tech, Inc.
K944611	MODEL# 7500 SURVEYOR	Apr 21, 1995	Substantially Equivalent	Devilbiss Health Care, Inc.
K940015	SNORING MICROPHONE, SM1	Jan 11, 1995	Substantially Equivalent	Pro-Tech, Inc.