QME — Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate Class II
FDA product code QME covers "Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate", a Class II medical device regulated under 21 CFR 870.2785. Submissions are reviewed by the Cardiovascular panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QME
- Device Class
- Class II
- Regulation Number
- 870.2785
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254169 | presage security, inc. d/b/a presage technologies | SmartSpectra Vital Signs Monitor 1.0 | June 18, 2026 |
| K253650 | nuralogix corporation | Anura Mobile Core SDK (M1) | June 11, 2026 |
| K260066 | panopticai technologies limited | PanopticAI Vital Signs (1.6.1-22) | May 21, 2026 |
| K251200 | oxehealth limited | Vital Signs | February 2, 2026 |
| K243687 | oxehealth limited | Vital Signs | August 27, 2025 |
| K250078 | mindset medical | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | May 30, 2025 |
| K240890 | panopticai technologies limited | PanopticAI Vital Signs | December 23, 2024 |
| K241633 | mindset medical | Informed Vital Core Application (IVC App) | November 18, 2024 |
| K232804 | qompium | FibriCheck | June 7, 2024 |
| K223622 | faceheart | FaceHeart Vitals Software Development Kit (FH vitals SDK) | September 1, 2023 |
| K220899 | oxehealth limited | Oxehealth Vital Signs | April 29, 2022 |
| K211906 | oxehealth limited | Vital Signs | July 20, 2021 |
| DEN200019 | oxehealth limited | Oxehealth Vital Signs | March 26, 2021 |