Cleared Traditional

K211452 - Encevis

K211452 is an FDA 510(k) clearance for Encevis, manufactured by Austrian Institute of Technology GmbH. The device is a Class 2 Neurology device with product code OMB cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K211452 · Austrian Institute of Technology GmbH · Neurology device
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Dec 2021
Decision
206d
Days
Class 2
Risk

K211452 is an FDA 510(k) clearance for the Encevis. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Austrian Institute of Technology GmbH (Vienna, AT). The FDA issued a Cleared decision on December 2, 2021 after a review of 206 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.

View all Austrian Institute of Technology GmbH devices

FDA 510(k) Submission Details - K211452

510(k) Number K211452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2021
Decision Date December 02, 2021
Days to Decision 206 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
58d slower than avg
Panel avg: 148d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMB Device Classification - Class 2, Special Controls

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By 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 - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 22
Devices cleared under the same product code (OMB) and FDA review panel - the closest regulatory comparables to K211452.
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