Cleared Traditional

K243513 - DCM (PW-DCM) (FDA 510(k) Clearance)

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

K243513 · Pneumowave, Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
155d
Days
Class 2
Risk

K243513 is an FDA 510(k) clearance for the DCM (PW-DCM). Classified as Device, Sleep Assessment (product code LEL), Class II - Special Controls.

Submitted by Pneumowave, Ltd. (Eurocentral, GB). The FDA issued a Cleared decision on April 16, 2025 after a review of 155 days - an extended review cycle.

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 Pneumowave, Ltd. devices

Submission Details

510(k) Number K243513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2024
Decision Date April 16, 2025
Days to Decision 155 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
7d slower than avg
Panel avg: 148d · This submission: 155d
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 18
Devices cleared under the same product code (LEL) and FDA review panel - the closest regulatory comparables to K243513.
EmbraceMini
K252981 · Empatica S.R.L. · Dec 2025
Sleep Watch
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VERABAND™
K233987 · Arbor Medical Innovations, LLC · Jun 2024
Oxevision Sleep Device
K233618 · Oxehealth Limited · Apr 2024
ActiGraph LEAP activity monitor (ActiGraph LEAP)
K231532 · Actigraph, LLC · Jun 2023