Cleared Traditional

K023859 - SMARTTROAE

K023859 is an FDA 510(k) clearance for SMARTTROAE, manufactured by Intelligent Hearing Systems. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K023859 · Intelligent Hearing Systems · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
49d
Days
Class 2
Risk

K023859 is an FDA 510(k) clearance for the SMARTTROAE. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on January 8, 2003 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - the FDA ear, nose and throat 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023859

510(k) Number K023859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date January 08, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 90d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 195
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K023859.
BIO-LOGIC INSERT EARPHONES
K031352 · Bio-Logic Systems Corp. · Jul 2003
TEOAE25
K030016 · Interacoustics A/S, Assens · Mar 2003
AUDIOSCREENER OAE+ABR
K024205 · Everest Biomedical Instruments Co. · Mar 2003
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · Bio-Logic Systems Corp. · Jun 2002
GSI AUDERA
K011135 · Nicolet Biomedical · Jul 2001
VIVO 200 DPS VIVOSCAN
K003364 · Vivosonic, Inc. · Jul 2001
K023859 · SMARTTROAE
Download PDF FDA Summary Intelligent Hearing S…