Cleared Traditional

K140530 - Electro Auricular Device

K140530 · Navigant Consulting, Inc. · Neurology device
Download Printable Device Report (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.

View all Navigant Consulting, Inc. devices

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

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -