Cleared Traditional

Vital Signs

K251200 · Oxehealth Limited · Cardiovascular

Feb 2026

Decision

290d

Days

Class 2

Risk

About This 510(k) Submission

K251200 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 February 2, 2026, 290 days after receiving the submission on April 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2785.

Submission Details

510(k) Number	K251200 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2025
Decision Date	February 02, 2026
Days to Decision	290 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.