| BedDot (G1) (K253274) | Intelligent Dots, LLC | 2026-06-25 |
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
| Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (K250093) | Linshom Medical, Inc. | 2025-09-26 |
| Respiree Cardio- Respiratory Monitor System (K250934) | Respiree Pte, Ltd. | 2025-08-05 |
| RTMsense Respiratory Monitoring System (K243183) | Rtm Vital Signs, LLC | 2025-06-27 |
| FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (K243966) | Faceheart Corp. | 2025-04-09 |
| Philips VSC-MEDlib (K242001) | Philips Medical Systems Nederland B.V. | 2025-04-04 |
| Makani Science™ Respiration Monitoring System (K233953) | Makani Science, Inc. | 2025-03-28 |
| Airmod (K242798) | Heroic Faith International , Ltd. | 2025-02-28 |
| Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (K240271) | Linshom Medical, Inc. | 2024-09-11 |
| Respiree Cardio-Respiratory Monitor (K223681) | Respiree Pte, Ltd. | 2023-03-08 |
| Dozee VS (K221555) | Turtle Shell Technologies Private Limited | 2022-12-15 |
| Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense (K223246) | Baxter Healthcare Corproration | 2022-11-18 |
| RespiraSense (K220111) | Pmd Solutions | 2022-10-07 |
| Breathe Easy Mobile Respiratory Monitor (MRM) (K211387) | Sound Life Sciences, Inc. | 2021-11-23 |
| Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation (K202018) | Hill-Rom, Inc. | 2021-03-04 |
| The C100 Contactless Breathing Monitor (K200445) | Circadia Technologies, Ltd. | 2020-06-24 |
| Linshom Respiratory Monitoring Device (LRMD) (K190734) | Linshom Management, LLC | 2020-01-30 |
| The RHEA Vital Sign Vigilance System (K190775) | Shenzhen Fiber Medical Technology Co. , Ltd. | 2019-12-19 |
| Masimo Acoustic Respiration Sensors, infant and neonate (K173976) | Masimo Corporation | 2018-09-05 |
| Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation (K180079) | Hill-Rom, Inc. | 2018-05-07 |
| EarlySense Bed Sensing Unit (K171836) | Earlysense, Ltd. | 2018-01-04 |
| EarlySense Insight Sytem (K152911) | Earlysense, Ltd. | 2016-05-06 |
| Thora-3Di, Model T-01 (K151940) | Pneumacare Limited | 2016-03-10 |
| CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM (K133661) | Earlysense, Ltd. | 2014-06-13 |
| INTELLIVUE CL RESPIRATION POD (K132320) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014-03-26 |
| NEUROVISION MEDICAL MOTION SENSOR (K130570) | Neurovision Medical Products, Inc. | 2013-12-26 |
| EARLYSENSE (K131379) | Earlysense, Ltd. | 2013-12-18 |
| NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO (K122223) | Philips Medizin Systeme Boeblingen GmbH | 2013-04-12 |
| EARLYSENSE (EVERON) SYSTEM (K120465) | Earlysense, Ltd. | 2012-06-08 |
| COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 (K111933) | Covidien | 2012-03-15 |
| SLEEPMINDER BREATHING FREQUENCY INDICATOR (K103631) | Biancamed Limited | 2011-07-21 |
| KAI SPOT MODEL KMS 200 (K100773) | Kai Medical, Inc. | 2010-06-23 |
| EVERON 1.0 (K092062) | Earlysense, Ltd. | 2010-05-24 |
| PNEUMOTHERML, MODEL: 5800 (K092685) | Salter Labs | 2009-11-24 |
| KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 (K090273) | Kai Sensors, Inc. | 2009-06-05 |
| EVERON (K082465) | Earlysense, Ltd. | 2009-03-25 |
| SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR (K080922) | Salter Labs, Division of Regulatory Affairs | 2008-07-25 |
| EARLYSENSE ES-16 SYSTEM (K070375) | Earlysense, Ltd. | 2007-11-15 |
| GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR (K062883) | Gereonics, Inc. | 2007-06-13 |
| ANDROFLOW - RESPIRATORY RATE MONITOR (K051779) | Andromed, Inc. | 2005-09-30 |
| DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 (K040605) | Dymedix, Inc. | 2004-04-26 |
| OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) (K003704) | Optovent AB | 2001-02-05 |
| ULTIMA SMARTBELT, MODEL 0560 (K001743) | Braebon Medical Corp. | 2000-08-25 |
| RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S (K001030) | Dymedix, Inc. | 2000-05-11 |
| GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR (K991411) | Gereonics, Inc. | 1999-04-28 |
| GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR (K983449) | Gereonics, Inc. | 1999-02-08 |
| OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 (K981725) | Optovent, Inc. | 1999-02-02 |
| ULTIMA AIRFLOW PRESSURE SENSOR (K984431) | Braebon Medical Corp. | 1998-12-30 |
| BROWSER (EVENT SOFTWARE) MODEL # 4500E (K982550) | Respironics, Inc. | 1998-10-05 |
| ULTIMA AIRFLOW SENSOR, 0510 (K981445) | Braebon Medical Corp. | 1998-10-05 |
| ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 (K982216) | Braebon Medical Corp. | 1998-09-11 |
| ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 (K981728) | Alexander Mfg. Co. | 1998-06-26 |
| MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR (K961972) | Aequitron Medical, Inc. | 1997-04-18 |
| COROMETRICS MODEL 510 AND 511 MONITOR (K962781) | Ge Medical Systems Information Technologies | 1997-03-06 |
| THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR (K960851) | Pro-Tech Services, Inc. | 1996-09-17 |
| OXIFLOW DIGITAL RECORDER (K953363) | Edentec Corp. | 1996-02-06 |
| MODEL 510 INFANT MONITOR (K943308) | Ge Medical Systems Information Technologies | 1995-07-25 |
| MODEL 511 INFANT MONITOR (K942170) | Ge Medical Systems Information Technologies | 1995-06-02 |
| SNORING SENSOR (K941759) | Epm Development Systems Corp. | 1994-11-10 |
| PLM SENSOR, MODEL PLM1 (K940014) | Pro-Tech, Inc. | 1994-11-10 |
| MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS (K924875) | Synectics-Dantec | 1994-06-30 |
| MOVING IMAGES(TM) (K935518) | Epm Information Systems, Inc. | 1994-05-17 |
| MAGNUM (K932902) | Sps, Inc. | 1994-05-10 |
| ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. (K930790) | Bio-Logic Systems Corp. | 1994-01-06 |
| MODEL MEDILOG RAPIDE (K923737) | Oxford Medilog, Inc. | 1994-01-05 |
| EDENTEC MODEL 3710 I DIGITAL PRINTER (K921819) | Edentec Corp. | 1993-10-22 |
| MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES (K925364) | Merit Medical Systems, Inc. | 1993-01-28 |
| CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR (K923402) | Pro-Tech, Inc. | 1992-12-30 |
| EASYFLOW (K922112) | Epm Information Systems, Inc. | 1992-12-07 |
| EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 (K913749) | Edentec Corp. | 1992-07-02 |
| SLEEPTRACE 2000 (K911874) | Areca Science Corp. | 1992-06-25 |
| SLEEPMASTER (K911386) | Biomedical Monitoring Systems, Inc. | 1992-04-24 |
| MEDICAL SAFETY CABLE AND LEAD SYSTEM (K912415) | Medtronic Vascular | 1991-08-16 |
| SLEEP I/T-5 AND SLEEP I/T-8 (K904432) | Cns, Inc. | 1991-07-10 |
| MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON (K905575) | Edentec Corp. | 1991-06-20 |
| MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION (K905520) | Synectics-Dantec | 1991-04-26 |
| RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 (K903020) | Aequitron Medical, Inc. | 1991-04-10 |
| RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL (K903011) | Non-Invasive Monitoring Systems, Inc. | 1991-03-29 |
| SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM (K904396) | Simplex Medical Systems, Inc. | 1991-03-05 |
| RESP-EZ(TM) RESPIRATORY MONITORING BELT (K903300) | Epm Information Systems, Inc. | 1990-12-28 |
| MODEL 900S APNEA/HEART MONITOR (K903287) | Healthdyne, Inc. | 1990-08-17 |
| R-BAND(TM) RESPIRATORY SENSOR (K900264) | Buckman Co., Inc. | 1990-07-24 |
| TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) (K884120) | S & W Medico Teknik | 1990-07-17 |
| MODEL 9200 RESPIRATION/HEART RATE MONITOR (K901656) | Aequitron Medical, Inc. | 1990-07-13 |
| MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON (K902785) | Aequitron Medical, Inc. | 1990-07-13 |
| KNIGHTWATCH SYSTEM (K896934) | Createch Corp. | 1990-06-25 |
| ARVEE APNEA MONITOR, MODEL 4800 (K900730) | Arvee Medical, Inc. | 1990-06-14 |
| MESAMIV RECORDER (K901466) | Madaus Medtec, Inc. | 1990-06-08 |
| 'APNEA-ELECTRODE' (K900826) | Medical Science Products, Inc. | 1990-04-26 |
| MESAM RECORDER (K894641) | Madaus Medtec, Inc. | 1990-01-22 |
| AR-800PA RESPIRATION MODULE (K891486) | Nihon Kohden America, Inc. | 1989-10-24 |
| ARVEE APNEA MONITOR, MODEL 2400 (K891676) | Arvee Medical, Inc. | 1989-09-06 |
| RESPIRATORY AIRWAY TUBE MONITOR (RATM) (K883158) | Vascucare, Inc. | 1989-03-06 |
| MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR (K884637) | Aequitron Medical, Inc. | 1989-01-30 |
| HEALTH-WATCH BED MONITOR (K882377) | Engineering Developments, Co. | 1988-11-02 |
| SAM(TM) MODEL ONE (K880725) | Sentel Tech. C/O Criticare Systems, Inc. | 1988-09-06 |
| 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS (K862747) | Atlas Researches , Ltd. | 1988-08-05 |
| MODEL 9216 RESPIRATION/HEART RATE MONITOR (K881266) | Aequitron Medical, Inc. | 1988-06-10 |
| BREATHGUARD APNEA MONITOR (K872833) | Lada Intl., Inc. | 1988-04-01 |