Cleared Traditional

K011181 - ICS MEDICAL CHARTR OAE WITH TYMP

K011181 is an FDA 510(k) clearance for ICS MEDICAL CHARTR OAE WITH TYMP, manufactured by Ics Medical Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K011181 · Ics Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
68d
Days
Class 2
Risk

K011181 is an FDA 510(k) clearance for the ICS MEDICAL CHARTR OAE WITH TYMP. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on June 25, 2001 after a review of 68 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 - K011181

510(k) Number K011181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2001
Decision Date June 25, 2001
Days to Decision 68 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
22d faster than avg
Panel avg: 90d · This submission: 68d
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 234
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K011181.
GSI AUDERA
K011135 · Nicolet Biomedical · Jul 2001
VIVO 200 DPS VIVOSCAN
K003364 · Vivosonic, Inc. · Jul 2001
ETYMOTIC RESEARCH ER-10D OAE PROBE
K011114 · Etymotic Research · Jul 2001
HINT AUDIOMETER, OR HINT
K003913 · Maico-Diagnostics · Mar 2001
ERO SCAN OAE TEST SYSTEM
K010165 · Etymotic Research · Mar 2001
CAPELLA
K002200 · Madsen Electronics, Inc. · Aug 2000
K011181 · ICS MEDICAL CHARTR OAE WITH TYMP
Download PDF FDA Summary Ics Medical Corp.