Cleared Traditional

K242113 - Nerve Wrap (07-DW-001-TAB)

K242113 is an FDA 510(k) clearance for Nerve Wrap (07-DW-001-TAB), manufactured by Biocircuit Technologies, Inc.. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K242113 · Biocircuit Technologies, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K242113

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.

JXI Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K242113.
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
NerveTape
K233533 · Biocircuit Technologies, Inc. · Feb 2024