Cleared Special

K241917 - EARP Nerve Cuff Electrode (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241917 · Retropsoas Technologies, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
30d
Days
Class 2
Risk

K241917 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 Retropsoas Technologies, LLC (Frontenac, US). The FDA issued a Cleared decision on July 31, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Retropsoas Technologies, LLC devices

Submission Details

510(k) Number K241917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2024
Decision Date July 31, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Peers - ETN Stimulator, Nerve

All 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K241917.
Evala Nerve Stimulator (EPNR002)
K253536 · Epineuron Technologies, Inc. · Feb 2026
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
Disposable Laryngeal Electrodes
K232888 · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 2023
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · Medtronic Xomed, Inc. · Oct 2023