Cleared Traditional

K143487 - Lifelines iEEG

K143487 is an FDA 510(k) clearance for Lifelines iEEG, manufactured by Kvikna Ehf. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K143487 · Kvikna Ehf · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
256d
Days
Class 2
Risk

K143487 is an FDA 510(k) clearance for the Lifelines iEEG. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Kvikna Ehf (Reykjavik, IS). The FDA issued a Cleared decision on August 21, 2015 after a review of 256 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 - K143487

510(k) Number K143487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2014
Decision Date August 21, 2015
Days to Decision 256 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
107d slower than avg
Panel avg: 149d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 Consultant

Smith Assoicates
Yolanda Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLT Non-normalizing Quantitative Electroencephalograph Software

All 45
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K143487.
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