Cleared Traditional

K213228 - NeuroLine Disposable Cranial Perforator with Hudson end (FDA 510(k) Clearance)

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

K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. · Neurology device
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Jun 2022
Decision
264d
Days
Class 2
Risk

K213228 is an FDA 510(k) clearance for the NeuroLine Disposable Cranial Perforator with Hudson end. Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. (Debrecen, HU). The FDA issued a Cleared decision on June 20, 2022 after a review of 264 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4305 - 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 Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. devices

Submission Details

510(k) Number K213228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date June 20, 2022
Days to Decision 264 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
116d slower than avg
Panel avg: 148d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBF Drills, Burrs, Trephines & Accessories (compound, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4305
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.