Cleared Traditional

K121119 - BNA ANALYSIS SYSTEM

K121119 is an FDA 510(k) clearance for BNA ANALYSIS SYSTEM, manufactured by Eiminda , Ltd.. The device is a Class 2 Neurology device with product code OLU cleared through the Traditional 510(k) pathway after a 834-day FDA review.

K121119 · Eiminda , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
834d
Days
Class 2
Risk

K121119 is an FDA 510(k) clearance for the BNA ANALYSIS SYSTEM. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by Eiminda , Ltd. (Herzliya, IL). The FDA issued a Cleared decision on July 25, 2014 after a review of 834 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K121119

510(k) Number K121119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2012
Decision Date July 25, 2014
Days to Decision 834 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
685d slower than avg
Panel avg: 149d · This submission: 834d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLU Device Classification - Class 2, Special Controls

Product Code OLU Normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database 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 Peers - OLU Normalizing Quantitative Electroencephalograph Software

All 12
Devices cleared under the same product code (OLU) and FDA review panel - the closest regulatory comparables to K121119.
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K121119 · BNA ANALYSIS SYSTEM
Download PDF FDA Summary Eiminda , Ltd.