Cleared Traditional

K260050 - WRAP System

K260050 is the FDA 510(k) clearance for WRAP System by Huneo, LLC. It is a Class 2 Neurology device (product code MNR) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K260050 · Huneo, LLC · Neurology device
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Jul 2026
Decision
189d
Days
Class 2
Risk

K260050 is an FDA 510(k) clearance for the WRAP System. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Huneo, LLC (Willoughby Hills, US). The FDA issued a Cleared decision on July 15, 2026 after a review of 189 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 868.2375 - 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.

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Submission Details

510(k) Number K260050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2026
Decision Date July 15, 2026
Days to Decision 189 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 148d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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.