Cleared Traditional

K213228 - NeuroLine Disposable Cranial Perforator...

K213228 is an FDA 510(k) clearance for NeuroLine Disposable Cranial Perforator..., manufactured by Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.. The device is a Class 2 Neurology device with product code HBF cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. · Neurology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K213228

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.

HBF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HBF Drills, Burrs, Trephines & Accessories (compound, Powered)

All 10
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K213228.
evoDrill Cranial Perforator
K231403 · Evonos GmbH & Co. KG · Mar 2024
Codman Disposable Perforators
K183581 · Integra Lifesciences Corp. · Jan 2019
CRANIAL PERFORATOR
K082637 · The Anspach Effort, Inc. · Dec 2008
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
K073336 · Codman & Shurtleff, Inc. · Jan 2008
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
K071931 · Codman & Shurtleff, Inc. · Oct 2007
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · The Anspach Effort, Inc. · Oct 1998