BZQ — Monitor, Breathing Frequency Class II
FDA product code BZQ covers "Monitor, Breathing Frequency", a Class II medical device regulated under 21 CFR 868.2375. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BZQ
- Device Class
- Class II
- Regulation Number
- 868.2375
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253274 | intelligent dots | BedDot (G1) | June 25, 2026 |
| K251326 | edwards lifesciences | Respiration Rate algorithm | June 11, 2026 |
| K250093 | linshom medical | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | September 26, 2025 |
| K250934 | respiree pte | Respiree Cardio- Respiratory Monitor System | August 5, 2025 |
| K243183 | rtm vital signs | RTMsense Respiratory Monitoring System | June 27, 2025 |
| K243966 | faceheart | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | April 9, 2025 |
| K242001 | philips medical systems nederland | Philips VSC-MEDlib | April 4, 2025 |
| K233953 | makani science | Makani Science Respiration Monitoring System | March 28, 2025 |
| K242798 | heroic faith international | Airmod | February 28, 2025 |
| K240271 | linshom medical | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | September 11, 2024 |
| K223681 | respiree pte | Respiree Cardio-Respiratory Monitor | March 8, 2023 |
| K221555 | turtle shell technologies private limited | Dozee VS | December 15, 2022 |
| K223246 | baxter healthcare corproration | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | November 18, 2022 |
| K220111 | pmd solutions | RespiraSense | October 7, 2022 |
| K211387 | sound life sciences | Breathe Easy Mobile Respiratory Monitor (MRM) | November 23, 2021 |
| K202018 | hill-rom | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom H | March 4, 2021 |
| K200445 | circadia technologies | The C100 Contactless Breathing Monitor | June 24, 2020 |
| K190734 | linshom management | Linshom Respiratory Monitoring Device (LRMD) | January 30, 2020 |
| K190775 | shenzhen fiber medical technology co. | The RHEA Vital Sign Vigilance System | December 19, 2019 |
| K173976 | masimo corporation | Masimo Acoustic Respiration Sensors, infant and neonate | September 5, 2018 |