Cleared Traditional

K260245 - SILKBridge (FDA 510(k) Clearance)

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

K260245 · KLISBio S.r.l. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
72d
Days
Class 2
Risk

K260245 is an FDA 510(k) clearance for the SILKBridge. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by KLISBio S.r.l. (Bresso, IT). The FDA issued a Cleared decision on April 9, 2026 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - 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 KLISBio S.r.l. devices

Submission Details

510(k) Number K260245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2026
Decision Date April 09, 2026
Days to Decision 72 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
76d faster than avg
Panel avg: 148d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
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

Bruder Consulting and Venture Group
Scott Bruder

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 - JXI Cuff, Nerve

All 39
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K260245.
NeuroSpan Bridge
K253363 · Auxilium Biotechnologies, Inc. · Jan 2026
VersaCoat Nerve Protector (VTP-44G2)
K251505 · Alafair Biosciences · Jul 2025
VersaWrap Nerve Protector (VTP-2201)
K251175 · Alafair Biosciences · Jul 2025
Nerve Wrap (07-DW-001-TAB)
K242113 · Biocircuit Technologies, Inc. · Apr 2025
Remplir (ON-152, 15 x 20 mm)
K243889 · Orthocell, Ltd. · Apr 2025
Mochida Nerve Cuff
K233322 · Mochida Pharmaceutical Co., Ltd. · Jun 2024