Cleared Traditional

K243687 - Vital Signs

K243687 is an FDA 510(k) clearance for Vital Signs, manufactured by Oxehealth Limited. The device is a Class 2 Cardiovascular device with product code QME cleared through the Traditional 510(k) pathway after a 271-day FDA review.

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

FDA 510(k) Submission Details - K243687

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.

QME Device Classification - Class 2, Special Controls

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 10
Devices cleared under the same product code (QME) and FDA review panel - the closest regulatory comparables to K243687.
PanopticAI Vital Signs (1.6.1-22)
K260066 · PanopticAI technologies Limited · May 2026
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