Cleared Traditional

ANSISTIM (K141168) - FDA 510(k) Clearance

K141168 · Dyansys, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
May 2015
Decision
374d
Days
-
Risk

K141168 is an FDA 510(k) clearance for the ANSISTIM. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel. 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.

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Submission Details

510(k) Number K141168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2014
Decision Date May 15, 2015
Days to Decision 374 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 148d · This submission: 374d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -