Cleared Traditional

K201376 - ANAM Test System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201376 · Vista Lifesciences, Inc. · Neurology device
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Mar 2021
Decision
303d
Days
Class 2
Risk

K201376 is an FDA 510(k) clearance for the ANAM Test System. Classified as Computerized Cognitive Assessment Aid For Concussion (product code POM), Class II - Special Controls.

Submitted by Vista Lifesciences, Inc. (Englewood, US). The FDA issued a Cleared decision on March 25, 2021 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1471 - 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. Elevated predicate reliance profile. 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 Vista Lifesciences, Inc. devices

Submission Details

510(k) Number K201376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2020
Decision Date March 25, 2021
Days to Decision 303 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
155d slower than avg
Panel avg: 148d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POM Computerized Cognitive Assessment Aid For Concussion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1471
Definition For Use As An Assessment Aid In The Management Of Concussion.
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.