Cleared Traditional

K991853 - INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

K991853 is an FDA 510(k) clearance for INTERACOUSTICS EP 15 ABR STAND ALONE UNIT, manufactured by Idem (Int'L Dist. of Electronics For Medicine). The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K991853 · Idem (Int'L Dist. of Electronics For Medicine) · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
146d
Days
Class 2
Risk

K991853 is an FDA 510(k) clearance for the INTERACOUSTICS EP 15 ABR STAND ALONE UNIT. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Idem (Int'L Dist. of Electronics For Medicine) (Benicia, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - the FDA neurology device framework. 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 Idem (Int'L Dist. of Electronics For Medicine) devices

FDA 510(k) Submission Details - K991853

510(k) Number K991853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date October 25, 1999
Days to Decision 146 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
2d faster than avg
Panel avg: 148d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 20
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