BZQ · Monitor, Breathing Frequency
Anesthesiology · 21 CFR 868.2375 · Class 2
Overview
| Product Code | BZQ |
|---|---|
| Device Name | Monitor, Breathing Frequency |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 174)
Showing 20 most recent of 174 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | Sep 26, 2025 | SESE |
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | Aug 5, 2025 | SESE |
| K243183 | RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC | Jun 27, 2025 | SESE |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | Apr 9, 2025 | SESE |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | Apr 4, 2025 | SESE |
| K233953 | Makani Science Respiration Monitoring System | Makani Science, Inc. | Mar 28, 2025 | SESE |
| K242798 | Airmod | Heroic Faith International , Ltd. | Feb 28, 2025 | SESE |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | Sep 11, 2024 | SESE |
| K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | Mar 8, 2023 | SESE |
| K221555 | Dozee VS | Turtle Shell Technologies Private Limited | Dec 15, 2022 | SESE |
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | Nov 18, 2022 | SESE |
| K220111 | RespiraSense | Pmd Solutions | Oct 7, 2022 | SESE |
| K211387 | Breathe Easy Mobile Respiratory Monitor (MRM) | Sound Life Sciences, Inc. | Nov 23, 2021 | SESE |
| 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 | SESE |
| K200445 | The C100 Contactless Breathing Monitor | Circadia Technologies, Ltd. | Jun 24, 2020 | SESE |
| K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | Jan 30, 2020 | SESE |
| K190775 | The RHEA Vital Sign Vigilance System | Shenzhen Fiber Medical Technology Co. , Ltd. | Dec 19, 2019 | SESE |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | Masimo Corporation | Sep 5, 2018 | SESE |
| 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 | SESE |
| K171836 | EarlySense Bed Sensing Unit | Earlysense, Ltd. | Jan 4, 2018 | SESE |
Top Applicants
- Aequitron Medical, Inc. — 9 clearances
- Earlysense, Ltd. — 8 clearances
- Healthdyne, Inc. — 8 clearances
- Edentec Corp. — 6 clearances
- Ge Medical Systems Information Technologies — 6 clearances
