Data / Medical devices / Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate (QME): 5 FDA-registered makers in 5 countries
5 establishments in 5 countries are registered with the FDA to make Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate (product code QME, Class 2, 21 CFR 870.2785). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on June 18, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QME
- Device class
- 2
- Regulation
- 870.2785
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 1 |
| India | 1 |
| Taiwan | 1 |
| United Kingdom | 1 |
| Belgium | 1 |
Makers of Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mindset Medical, Inc. | Phoenix, AZ, United States | Manufacturer | 2 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Blue Cloud Softech Solutions Ltd | Hyderabad Telangana, India | Manufacturer, Specification developer | 1 | September 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Faceheart Corp. | Taiwan Hsinchu(City), Taiwan | Manufacturer | 1 | September 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Oxehealth Ltd | Abingdon Oxfordshire, United Kingdom | Manufacturer | 1 | March 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Qompium NV | Hasselt Limburg, Belgium | Manufacturer | 1 | June 7, 2024 | 0 | 0 | 0 | api.fda.gov |
Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.