BZQ
- Product code
- BZQ
- Device name
- Monitor, Breathing Frequency
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.2375
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 176 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253274 | 2026-06-25 | Intelligent Dots, LLC | BedDot (G1) | |
| K251326 | 2026-06-11 | Edwards Lifesciences, LLC | Respiration Rate algorithm | |
| K250093 | 2025-09-26 | Linshom Medical, Inc. | Linshom Continuous Predictive Respiratory Monitoring… | |
| K250934 | 2025-08-05 | Respiree Pte, Ltd. | Respiree Cardio- Respiratory Monitor System | |
| K243183 | 2025-06-27 | Rtm Vital Signs, LLC | RTMsense Respiratory Monitoring System | |
| K243966 | 2025-04-09 | Faceheart Corp. | FaceHeart Vitals Software Development Kit (FH vitals… | |
| K242001 | 2025-04-04 | Philips Medical Systems Nederland B.V. | Philips VSC-MEDlib | |
| K233953 | 2025-03-28 | Makani Science, Inc. | Makani Science Respiration Monitoring System | |
| K242798 | 2025-02-28 | Heroic Faith International , Ltd. | Airmod | |
| K240271 | 2024-09-11 | Linshom Medical, Inc. | Linshom Continuous Predictive Respiratory Monitoring… | FDA |
Official FDA classification page: BZQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).