Cleared Traditional

K140680 - LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM

K140680 is an FDA 510(k) clearance for LEADPOINT FOCUS WORKSTSTION, manufactured by Alpine Biomed Aps. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K140680 · Alpine Biomed Aps · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
269d
Days
Class 2
Risk

K140680 is an FDA 510(k) clearance for the LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Alpine Biomed Aps (Skovlunde, DK). The FDA issued a Cleared decision on December 12, 2014 after a review of 269 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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.

FDA 510(k) Submission Details - K140680

510(k) Number K140680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date December 12, 2014
Days to Decision 269 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
120d slower than avg
Panel avg: 149d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K140680.
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
K163355 · Ad-Tech Medical Instrument Corporation · Apr 2017
PMT Platinum Depthalon Depth Electrode
K151790 · Pmt Corporation · Jul 2016
DNAP Electrode
K152547 · Ad-Tech Medical Instrument Corporation · Mar 2016
NEURO OMEGA SYSTEM
K123796 · Alpha Omega Engineering , Ltd. · Apr 2013
STERILE DISPOSABLES FOR MER
K120098 · Alpha Omega Engineering , Ltd. · Jun 2012
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
K110010 · Blackrock Microsystems, Inc. · Feb 2011
K140680 · LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
Download PDF FDA Summary Alpine Biomed Aps