Cleared Traditional

K133980 - PANTHEON ELECTROSTIMULATOR

K133980 · Pantheon Research · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 149d · This submission: 315d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 18
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K133980.
ANSiStim-PP
K170391 · Dyansys, Inc. · Mar 2017
Stivax
K152571 · Biegler GmbH · May 2016
ANSISTIM
K141168 · Dyansys, Inc. · May 2015
Electro Auricular Device
K140530 · Navigant Consulting, Inc. · Oct 2014
P-STIM
K140788 · Biegler GmbH · Jun 2014
JIAJIAN CMN STIMULATOR
K130768 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2013
K133980 · PANTHEON ELECTROSTIMULATOR
Download PDF FDA Summary Pantheon Research