Cleared Traditional

K230853 - EARP Nerve Cuff Electrode (FDA 510(k) Clearance)

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

K230853 · Nvision Biomedical Technologies, Inc. · Neurology device
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Oct 2023
Decision
192d
Days
Class 2
Risk

K230853 is an FDA 510(k) clearance for the EARP Nerve Cuff Electrode. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on October 6, 2023 after a review of 192 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - 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 Nvision Biomedical Technologies, Inc. devices

Submission Details

510(k) Number K230853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2023
Decision Date October 06, 2023
Days to Decision 192 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
44d slower than avg
Panel avg: 148d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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

Watershed Idea Foundry
Jeffrey Brittan

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 - ETN Stimulator, Nerve

All 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K230853.
Evala Nerve Stimulator (EPNR002)
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NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672 · Medtronic Xomed, Inc. · Feb 2026
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
K242852 · Inomed Medizintechnik GmbH · Jun 2025
Bioscope Neuromonitor Device
K233001 · Biosys Biyomedikal Muhendislik San. VE Tic. A.S. · Dec 2024
EARP Nerve Cuff Electrode
K241917 · Retropsoas Technologies, LLC · Jul 2024
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · Medtronic Xomed, Inc. · Oct 2023