Cleared Traditional

K252051 - allay Nerve Cap (TL5515-1) (FDA 510(k) Clearance)

Also includes:
allay Nerve Cap (TL5515-2) Delivery Tips (TL-7627)

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

K252051 · Tulavi Therapeutics, Inc. · Neurology device
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Sep 2025
Decision
90d
Days
Class 2
Risk

K252051 is an FDA 510(k) clearance for the allay Nerve Cap (TL5515-1). Classified as In Situ Polymerizing Peripheral Nerve Cap (product code SBG), Class II - Special Controls.

Submitted by Tulavi Therapeutics, Inc. (Los Gatos, US). The FDA issued a Cleared decision on September 29, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5260 - 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 Tulavi Therapeutics, Inc. devices

Submission Details

510(k) Number K252051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2025
Decision Date September 29, 2025
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SBG In Situ Polymerizing Peripheral Nerve Cap
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5260
Definition An In Situ Polymerizing Peripheral Nerve Cap Is A Prescription Use Only Device Composed Of Precursor Materials That Polymerize When Delivered To The End Of A Peripheral Nerve To Function As A Physical Barrier To The Surrounding In Vivo Environment To Reduce The Risk Of Formation Of A Symptomatic Neuroma.
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

Hogan Lovells
Janice Hogan

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.