Cleared Traditional

K140680 - LEADPOINT FOCUS WORKSTSTION

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
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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.

View all Alpine Biomed Aps devices

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
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 148d · 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 25
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K140680.
microTargeting Guideline 4000 5.0 System
K183123 · FHC, Inc. · Dec 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544 · Ad-Tech Medical Instrument Corporation · Aug 2018
NeuroNav System, NeuroSmart System
K172042 · Alpha Omega Engineering , Ltd. · Feb 2018
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
K053358 · Ad-Tech Medical Instrument Corp · May 2006
MACRO-MICRO DEPTH ELECTRODE
K041604 · Ad-Tech Medical Instrument Corp · Aug 2004
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · Pmt Corp. · Aug 2004