Cleared Traditional

K253580 - Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S) (FDA 510(k) Clearance)

Also includes:
Sterile, Insulated Dilator, 20mm (MDT-0469S)

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

K253580 · Tedan Surgical Innovations · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
160d
Days
Class 2
Risk

K253580 is an FDA 510(k) clearance for the Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S). Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Tedan Surgical Innovations (Sugar Land, US). The FDA issued a Cleared decision on April 26, 2026 after a review of 160 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.

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Submission Details

510(k) Number K253580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date April 26, 2026
Days to Decision 160 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
12d slower than avg
Panel avg: 148d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
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.