Cleared Traditional

K202234 - NervAlign Nerve Cuff (FDA 510(k) Clearance)

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

K202234 · Renerve, Ltd. · Neurology device
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Feb 2022
Decision
552d
Days
Class 2
Risk

K202234 is an FDA 510(k) clearance for the NervAlign Nerve Cuff. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Renerve, Ltd. (North Melbourne, AU). The FDA issued a Cleared decision on February 10, 2022 after a review of 552 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Renerve, Ltd. devices

Submission Details

510(k) Number K202234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2020
Decision Date February 10, 2022
Days to Decision 552 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
404d slower than avg
Panel avg: 148d · This submission: 552d
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

Sloan Regulatory Consulting, LLC
Chris Sloan

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 K202234.
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
Nerve Wrap (07-DW-001-TAB)
K242113 · Biocircuit Technologies, Inc. · Apr 2025
Remplir (ON-152, 15 x 20 mm)
K243889 · Orthocell, Ltd. · Apr 2025