Cleared Traditional

Oxevision Sleep Device (K233618) - FDA 510(k) Clearance

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

K233618 · Oxehealth Limited · Neurology device
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Apr 2024
Decision
142d
Days
Class 2
Risk

K233618 is an FDA 510(k) clearance for the Oxevision Sleep Device. Classified as Device, Sleep Assessment (product code LEL), Class II - Special Controls.

Submitted by Oxehealth Limited (Oxford, GB). The FDA issued a Cleared decision on April 3, 2024 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxehealth Limited devices

Submission Details

510(k) Number K233618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date April 03, 2024
Days to Decision 142 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 148d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEL Device, Sleep Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Neurology devices follow this clearance model.

Regulatory Peers - LEL Device, Sleep Assessment

All 7
Devices cleared under the same product code (LEL) and FDA review panel - the closest regulatory comparables to K233618.
Sleep Watch
K251574 · Ambulatory Monitoring, Inc. · Jul 2025
DCM (PW-DCM)
K243513 · Pneumowave, Ltd. · Apr 2025
VERABAND™
K233987 · Arbor Medical Innovations, LLC · Jun 2024
ActiGraph LEAP activity monitor (ActiGraph LEAP)
K231532 · Actigraph, LLC · Jun 2023
ActiGraph CentrePoint Insight Watch
K181077 · Actigraph · May 2018
REMVIEW SLEEP RECORDER, MODEL 320
K003499 · Respironics, Inc. · Feb 2001