Cleared Traditional

K024316 - NIM-PRS

K024316 is an FDA 510(k) clearance for NIM-PRS, manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K024316 · Medtronic Xomed, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
11d
Days
Class 2
Risk

K024316 is an FDA 510(k) clearance for the NIM-PRS. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 6, 2003 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K024316

510(k) Number K024316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2002
Decision Date January 06, 2003
Days to Decision 11 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 148d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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

Citech
ROBERT MOSENKIS

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.

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