Not Cleared Direct

Oxehealth Vital Signs (DEN200019) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200019 · Oxehealth Limited · Cardiovascular device
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Mar 2021
Decision
364d
Days
Class 2
Risk

DEN200019 is an FDA 510(k) submission (not cleared) for the Oxehealth 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 (Oxford, GB). The FDA issued a Not Cleared (DENG) decision on March 26, 2021 after a review of 364 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 364 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Oxehealth Limited devices

Submission Details

510(k) Number DEN200019 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 27, 2020
Decision Date March 26, 2021
Days to Decision 364 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 125d · This submission: 364d
Pathway characteristics

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.