Cleared Traditional

K133980 - PANTHEON ELECTROSTIMULATOR

K133980 · Pantheon Research · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
315d
Days
-
Risk

K133980 is an FDA 510(k) clearance for the PANTHEON ELECTROSTIMULATOR. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Pantheon Research (Crofton, US). The FDA issued a Cleared decision on November 7, 2014 after a review of 315 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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FDA 510(k) Submission Details - K133980

510(k) Number K133980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2013
Decision Date November 07, 2014
Days to Decision 315 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
167d slower than avg
Panel avg: 148d · This submission: 315d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -