Cleared Traditional

K262515 - Kneu Platform (V2)

K262515 is an FDA 510(k) clearance for Kneu Platform (V2), manufactured by Kneu Health Digital , Ltd.. The device is a Class 2 Neurology device with product code GYD cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K262515 · Kneu Health Digital , Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Aug 2026
Decision
30d
Days
Class 2
Risk

K262515 is an FDA 510(k) clearance for the Kneu Platform (V2). Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by Kneu Health Digital , Ltd. (London, GB). The FDA issued a Cleared decision on August 20, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1950 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kneu Health Digital , Ltd. devices

FDA 510(k) Submission Details - K262515

510(k) Number K262515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2026
Decision Date August 20, 2026
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GYD Device Classification - Class 2, Special Controls

Product Code GYD Transducer, Tremor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1950
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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GYD Transducer, Tremor

All 11
Devices cleared under the same product code (GYD) and FDA review panel - the closest regulatory comparables to K262515.
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