Cleared Traditional

Vital Signs

K243687 · Oxehealth Limited · Cardiovascular

Aug 2025

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K243687 is an FDA 510(k) clearance for the Vital Signs, 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 review panel. Regulated under 21 CFR 870.2785.

Submission Details

510(k) Number	K243687 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.