Cleared Traditional

K242113 - Nerve Wrap (07-DW-001-TAB) (FDA 510(k) Clearance)

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

K242113 · Biocircuit Technologies, Inc. · Neurology device
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Apr 2025
Decision
257d
Days
Class 2
Risk

K242113 is an FDA 510(k) clearance for the Nerve Wrap (07-DW-001-TAB). Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Biocircuit Technologies, Inc. (Atlanta, US). The FDA issued a Cleared decision on April 2, 2025 after a review of 257 days - an extended review 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: 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 Biocircuit Technologies, Inc. devices

Submission Details

510(k) Number K242113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2024
Decision Date April 02, 2025
Days to Decision 257 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
109d slower than avg
Panel avg: 148d · This submission: 257d
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 Peers - JXI Cuff, Nerve

All 39
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K242113.
SILKBridge
K260245 · KLISBio S.r.l. · Apr 2026
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
Remplir (ON-152, 15 x 20 mm)
K243889 · Orthocell, Ltd. · Apr 2025
Mochida Nerve Cuff
K233322 · Mochida Pharmaceutical Co., Ltd. · Jun 2024