Part 868 Subpart C—Monitoring Devices
FDA submissions for Part 868 Subpart C—Monitoring Devices in the Anesthesiology (AN) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 868.2025–868.2900
CFR Part: 868
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| CBA | Monitor, Air Embolism, Ultrasonic | 868.2025 | 2 | 1 |
| QVE | Adjunctive Pain Measurement Device For Anesthesiology | 868.2200 | 2 | 1 |
| QVT | Monitor For Opioid Induced Impairment Of Oxygenation | 868.2250 | 2 | 1 |
| CCN | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | 868.2300 | 1 | 9 |
| BYM | Tube, Thorpe, Uncompensated | 868.2320 | 1 | 1 |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 868.2340 | 1 | 24 |
| BXY | Flowmeter, Calibration, Gas | 868.2350 | 1 | 7 |
| BZQ | Monitor, Breathing Frequency | 868.2375 | 2 | 174 |
| MNR | Ventilatory Effort Recorder | 868.2375 | 2 | 160 |
| PRK | Device Indicating An Exhalation Event | 868.2375 | 2 | 1 |
| FLS | Monitor, Apnea, Facility Use | 868.2377 | 2 | 16 |
| NPF | Monitor, Apnea, Home Use | 868.2377 | 2 | 2 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 868.2378 | 2 | 2 |
| MRP | Analyzer, Nitric Oxide | 868.2380 | 2 | 1 |
| MRQ | Analyzer, Nitrogen Dioxide | 868.2385 | 2 | 0 |
| PUG | Analyzer, Nitrogen Dioxide, Exempt | 868.2385 | 2 | 0 |
| JEZ | Monitor, Lung Water Measurement | 868.2450 | 3 | 1 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 868.2480 | 2 | 17 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 868.2500 | 2 | 47 |
| LPP | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | 868.2500 | 2 | 2 |
| JAX | Pneumotachometer | 868.2550 | 2 | 8 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 868.2600 | 2 | 78 |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | 868.2610 | 1 | 4 |
| PXE | Pressure Monitoring (Air/Gas) Kit | 868.2610 | 1 | 0 |
| BXX | Calibrator, Pressure, Gas | 868.2620 | 1 | 10 |
| CAN | Regulator, Pressure, Gas Cylinder | 868.2700 | 1 | 55 |
| ECX | Cylinder, Compressed Gas, And Valve | 868.2700 | 1 | 13 |
| BXM | Stimulator, Nerve, Ac-Powered | 868.2775 | 2 | 4 |
| BXN | Stimulator, Nerve, Battery-Powered | 868.2775 | 2 | 63 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 868.2775 | 2 | 28 |
| BYR | Transducer, Gas Pressure, Differential | 868.2875 | 1 | 3 |
| BXP | Transducer, Gas Flow | 868.2885 | 1 | 7 |
| BXO | Transducer, Gas Pressure | 868.2900 | 1 | 2 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K252497 | SANSA HSAT | Huxley Medical | Dec 10, 2025 |
| K250882 | SANSA HSAT | Huxley Medical | Oct 29, 2025 |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | Oct 21, 2025 |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | Sep 26, 2025 |
| K250460 | WatchPAT400 (WP400) | Itamar Medical , Ltd. | Sep 5, 2025 |
| K252383 | Somfit D | Compumedics Limited | Aug 28, 2025 |
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | Aug 5, 2025 |
| K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | Jul 3, 2025 |
| K243183 | RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC | Jun 27, 2025 |
| K243339 | WiTOF | Idmed | Jun 23, 2025 |
| K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | Jun 18, 2025 |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | Apr 9, 2025 |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | Apr 4, 2025 |
| K233953 | Makani Science Respiration Monitoring System | Makani Science, Inc. | Mar 28, 2025 |
| K243092 | AcuPebble Ox (200) | Acurable Limited | Mar 19, 2025 |
| K242798 | Airmod | Heroic Faith International , Ltd. | Feb 28, 2025 |
| K243268 | TipTraQ (TTQ001) | Pranaq Pte. , Ltd. | Feb 3, 2025 |
| K244027 | SANSA HSAT | Huxley Medical | Jan 28, 2025 |
| K242290 | DormoTech NLab | Dormotech Medical, Ltd. | Jan 8, 2025 |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. | Dec 18, 2024 |
| K242525 | iTOF® | Nerbio Medical Software Platforms, Inc. | Dec 5, 2024 |
| K240929 | Sleep Apnea Notification Feature (SANF) | Apple, Inc. | Sep 13, 2024 |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | Sep 11, 2024 |
| K231667 | Withings Sleep Rx | Withings | Sep 6, 2024 |
| K233501 | LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. | Jul 26, 2024 |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | Jul 15, 2024 |
| K240100 | SAM Model 9-10000 | Snap Diagnostics, LLC | Jun 4, 2024 |
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | May 17, 2024 |
| K231355 | Aurora | Ensodata | Feb 9, 2024 |
| DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., Ltd. | Feb 6, 2024 |
| K231546 | Somfit | Compumedics Limited | Nov 30, 2023 |
| K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | Aug 18, 2023 |
| DEN200011 | Masimo SafetyNet | Masimo Corporation | Mar 31, 2023 |
| K221816 | Wesper Lab | Wesper, Inc. | Mar 9, 2023 |
| K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | Mar 8, 2023 |
| K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | Feb 23, 2023 |
| DEN210022 | PMD-200 | Medasense Biometrics , Ltd. | Feb 17, 2023 |
| K222950 | AcuPebble OX100 | Acurable Limited | Feb 3, 2023 |
| K223675 | WatchPAT ONE (WP1) | Itamar Medical , Ltd. | Jan 6, 2023 |
| K220012 | BresoDX1 | Bresotec, Inc. | Dec 21, 2022 |
| K221555 | Dozee VS | Turtle Shell Technologies Private Limited | Dec 15, 2022 |
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | Nov 18, 2022 |
| K213049 | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | Oct 16, 2022 |
| K220111 | RespiraSense | Pmd Solutions | Oct 7, 2022 |
| K222331 | WatchPAT300 (WP300) | Itamar Medical , Ltd. | Sep 14, 2022 |
| K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | Aug 17, 2022 |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | Jul 21, 2022 |
| K220095 | ANNE Sleep | Sibel, Inc. | Jul 11, 2022 |
| K213360 | SleepCheckRx | Resapp Health | Jul 5, 2022 |
| K212434 | Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut für Physik und Medizin GmbH | May 5, 2022 |
| K210593 | Onera Sleep Test System (Onera STS) | Onera B.V. | Apr 6, 2022 |
| K203839 | WatchPAT200U (WP200U) | Itamar Medical , Ltd. | Mar 21, 2022 |
| K220028 | NightOwl | Ectosense NV | Feb 24, 2022 |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM | Nihon Kohden Corporation | Dec 29, 2021 |
| K203343 | Wesper Lab | Wesper, Inc. | Dec 21, 2021 |
| K213463 | NightOwl | Ectosense NV | Dec 16, 2021 |
| K211387 | Breathe Easy Mobile Respiratory Monitor (MRM) | Sound Life Sciences, Inc. | Nov 23, 2021 |
| K210480 | AcuPebble SA | Acurable Limited | Jul 6, 2021 |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | Nihon Kohden Corporation | May 2, 2021 |
| K202018 | 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 | Hill-Rom, Inc. | Mar 4, 2021 |
| K201495 | Maxxi Flow Sensor | Neurovirtual USA, Inc. | Dec 14, 2020 |
| K201666 | SINGLE USE MANOMETER | Flexicare Medical Limited. | Nov 13, 2020 |
| K200695 | MATRx plus | Zephyr Sleep Technologies | Aug 24, 2020 |
| K200654 | Rubicon SA System | Dymedix Diagnostics, Inc. | Jul 22, 2020 |
| K200445 | The C100 Contactless Breathing Monitor | Circadia Technologies, Ltd. | Jun 24, 2020 |
| K192958 | TwitchView System | Blink Device Company | Apr 2, 2020 |
| K191031 | NightOwl | Ectosense NV | Mar 6, 2020 |
| K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | Jan 30, 2020 |
| K191095 | Maxxi Snore Sensor | Neurovirtual USA, Inc. | Jan 16, 2020 |
| K190775 | The RHEA Vital Sign Vigilance System | Shenzhen Fiber Medical Technology Co. , Ltd. | Dec 19, 2019 |
| K191925 | MATRx Plus | Zephyr Sleep Technologies | Oct 29, 2019 |
| K190795 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | Oct 18, 2019 |
| K183625 | SomnaPatch | Respironics, Inc. | Oct 18, 2019 |
| K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant | Embla Systems | Sep 27, 2019 |
| K182292 | VORTRAN APM-Plus | Vortran Medical Technology 1, Inc. | Sep 18, 2019 |
| K182618 | SleepImage System | Mycardio, LLC Dba Sleepimage. | Aug 14, 2019 |
| K173974 | DROWZLE | Resonea, Inc. | Jul 14, 2019 |
| K171304 | Maxxi Rip Sensor | Neurovirtual USA, Inc. | Jun 24, 2019 |
| K183559 | WatchPAT ONE | Itamar Medical , Ltd. | Jun 5, 2019 |
| K180510 | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. | May 1, 2019 |
| K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | Mar 1, 2019 |
| K181996 | MATRx Plus | Zephyr Sleep Technologies | Nov 21, 2018 |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | Masimo Corporation | Sep 5, 2018 |
| K180775 | Watch-PAT300 | Itamar Medical , Ltd. | Aug 17, 2018 |
| K172690 | ToFscan | Idmed | May 31, 2018 |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | Hill-Rom, Inc. | May 7, 2018 |
| K172843 | TwitchView System | Blink Device Corporation | Mar 29, 2018 |
| K172799 | Positional Sleep Assessment System (PoSAS) software | Advanced Brain Monitoring | Mar 9, 2018 |
| K172284 | NAPA LP-15 Airway Pressure Monitor | Drw Medical, LLC | Feb 9, 2018 |
| K171836 | EarlySense Bed Sensing Unit | Earlysense, Ltd. | Jan 4, 2018 |
| K163696 | SleepImage System | Mycardio, LLC Dba Sleepimage. | Oct 13, 2017 |
| K163665 | MATRx plus | Zephyr Sleep Technologies | May 5, 2017 |
| K160499 | Apnea Risk Evaluation System (ARES), Model 620 | Watermark Medical | Apr 24, 2017 |
| K161179 | Intelli-Ox | Air Liquide Healthcare America Corporation | Apr 13, 2017 |
| K162811 | MR Conditional CGA 870 | Essex Industries, Inc. | Mar 2, 2017 |
| K161579 | Watch-PAT200U | Itamar Medical , Ltd. | Feb 24, 2017 |
| K161953 | ReDe Mask | Tereopneuma | Feb 17, 2017 |
| K162086 | MultiStim ECO | PAJUNK GmbH Medizintechnologie | Jan 6, 2017 |
| K162048 | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | Halyard Health - Irvine | Dec 5, 2016 |
| K161472 | Walk-O2-Bout | Essex Industries, Inc. | Nov 18, 2016 |
