Cleared Traditional

K140530 - Electro Auricular Device (FDA 510(k) Clearance)

K140530 · Navigant Consulting, Inc. · Neurology device
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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.

View all Navigant Consulting, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 148d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 22
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K140530.
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
K244030 · Wuxi Jiajian Medical Instrument Co., Ltd. · Mar 2025
Needle Stimulator (Model: RJNS6-1)
K220153 · Bozhou Rongjian Medical Appliance Co., Ltd. · Mar 2022
Needle Stimulator
K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · Lhasa Oms, Inc. · Feb 2021