Cleared Traditional

K240189 - NM-01/CPT neurometer (NM-01/CPT) (FDA 510(k) Clearance)

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

K240189 · Mde Orvosbiol?giai Kutat?, Fejleszto, · Neurology device
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Mar 2025
Decision
427d
Days
Class 2
Risk

K240189 is an FDA 510(k) clearance for the NM-01/CPT neurometer (NM-01/CPT). Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Mde Orvosbiol?giai Kutat?, Fejleszto, (Budapest, HU). The FDA issued a Cleared decision on March 26, 2025 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - 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 Mde Orvosbiol?giai Kutat?, Fejleszto, devices

Submission Details

510(k) Number K240189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2024
Decision Date March 26, 2025
Days to Decision 427 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
279d slower than avg
Panel avg: 148d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
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.