Cleared Traditional

K243687 - Vital Signs (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243687 · Oxehealth Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
271d
Days
Class 2
Risk

K243687 is an FDA 510(k) clearance for the Vital Signs. Classified as Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (product code QME), Class II - Special Controls.

Submitted by Oxehealth Limited (Abingdon, GB). The FDA issued a Cleared decision on August 27, 2025 after a review of 271 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2785 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxehealth Limited devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 125d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QME Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate

All 9
Devices cleared under the same product code (QME) and FDA review panel - the closest regulatory comparables to K243687.
Vital Signs
K251200 · Oxehealth Limited · Feb 2026
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
K250078 · Mindset Medical, Inc. · May 2025
PanopticAI Vital Signs
K240890 · PanopticAI technologies Limited · Dec 2024
Informed Vital Core Application (IVC App)
K241633 · Mindset Medical, Inc. · Nov 2024
FibriCheck
K232804 · Qompium NV · Jun 2024
FaceHeart Vitals Software Development Kit (FH vitals SDK)
K223622 · Faceheart Corp. · Sep 2023