K243687 is an FDA 510(k) clearance for the Vital Signs. This device is classified as a Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (Class II - Special Controls, product code QME).
Submitted by Oxehealth Limited (Abingdon, GB). The FDA issued a Cleared decision on August 27, 2025, 271 days after receiving the submission on November 29, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2785. 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..
| 510(k) Number | K243687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2024 |
| Decision Date | August 27, 2025 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QME - Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2785 |
| 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. |