Cleared Traditional

K243513 - DCM (PW-DCM)

K243513 is an FDA 510(k) clearance for DCM (PW-DCM), manufactured by Pneumowave, Ltd.. The device is a Class 2 Neurology device with product code LEL cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K243513 · Pneumowave, Ltd. · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K243513

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.

LEL Device Classification - Class 2, Special Controls

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 9
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