Cleared Traditional

K140530 - Electro Auricular Device

K140530 · Navigant Consulting, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
212d
Days
-
Risk

K140530 is an FDA 510(k) clearance for the Electro Auricular Device. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Navigant Consulting, Inc. (Chicago, US). The FDA issued a Cleared decision on October 2, 2014 after a review of 212 days - an extended review cycle.

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. 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.

FDA 510(k) Submission Details - K140530

510(k) Number K140530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2014
Decision Date October 02, 2014
Days to Decision 212 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
63d slower than avg
Panel avg: 149d · This submission: 212d
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 K140530.
Stivax
K152571 · Biegler GmbH · May 2016
ANSISTIM
K141168 · Dyansys, Inc. · May 2015
PANTHEON ELECTROSTIMULATOR
K133980 · Pantheon Research · Nov 2014
P-STIM
K140788 · Biegler GmbH · Jun 2014
JIAJIAN CMN STIMULATOR
K130768 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2013
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
K122812 · Wuxi Jiajian Medical Instrument Co., Ltd. · Apr 2013
K140530 · Electro Auricular Device
Download PDF FDA Summary Navigant Consulting, …