Cleared Traditional

K894097 - NTI-1000

K894097 is an FDA 510(k) clearance for NTI-1000, manufactured by Neurotek, Inc.. The device is a Class 2 Neurology device with product code QJQ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K894097 · Neurotek, Inc. · Neurology device
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Sep 1989
Decision
108d
Days
Class 2
Risk

K894097 is an FDA 510(k) clearance for the NTI-1000. Classified as Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (product code QJQ), Class II - Special Controls.

Submitted by Neurotek, Inc. (Olathe, US). The FDA issued a Cleared decision on September 25, 1989 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5800 - 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 Neurotek, Inc. devices

FDA 510(k) Submission Details - K894097

510(k) Number K894097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date September 25, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 148d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJQ Device Classification - Class 2, Special Controls

Product Code QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5800
Definition To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety
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.