RTMsense Respiratory Monitoring System
FDA 510(k) K243183 · Rtm Vital Signs, LLC
510(k) numberK243183
Submission
- Device name
- RTMsense Respiratory Monitoring System
- Applicant
- Rtm Vital Signs, LLC
Ambler, PA, US - Received
- September 30, 2024
- Decision date
- June 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
Other 510(k)s with product code BZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253274 | BedDot (G1)BZQ · Traditional | Intelligent Dots, LLC | 06/25/2026SE |
| K251326 | Respiration Rate algorithmBZQ · Traditional | Edwards Lifesciences, LLC | 06/11/2026SE |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)BZQ · Traditional | Linshom Medical, Inc. | 09/26/2025SE |
| K250934 | Respiree Cardio- Respiratory Monitor SystemBZQ · Traditional | Respiree Pte, Ltd. | 08/05/2025SE |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)BZQ · Traditional | Faceheart Corp. | 04/09/2025SE |
| K242001 | Philips VSC-MEDlibBZQ · Traditional | Philips Medical Systems Nederland B.V. | 04/04/2025SE |
| K233953 | Makani Science Respiration Monitoring SystemBZQ · Traditional | Makani Science, Inc. | 03/28/2025SE |
| K242798 | AirmodBZQ · Traditional | Heroic Faith International , Ltd. | 02/28/2025SE |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)BZQ · Traditional | Linshom Medical, Inc. | 09/11/2024SE |
| K223681 | Respiree Cardio-Respiratory MonitorBZQ · Traditional | Respiree Pte, Ltd. | 03/08/2023SE |
Questions and answers
When was RTMsense Respiratory Monitoring System cleared by the FDA?
RTMsense Respiratory Monitoring System (K243183) received a 510(k) decision of Substantially Equivalent on June 27, 2025, 270 days after the submission was received.
What is the product code of K243183?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.