Cleared Traditional

K001058 - AUDIOSCREENER OAE + ABR

K001058 is an FDA 510(k) clearance for AUDIOSCREENER OAE + ABR, manufactured by Kedly, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K001058 · Kedly, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
60d
Days
Class 2
Risk

K001058 is an FDA 510(k) clearance for the AUDIOSCREENER OAE + ABR. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Kedly, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 2, 2000 after a review of 60 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 - K001058

510(k) Number K001058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2000
Decision Date June 02, 2000
Days to Decision 60 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
30d faster than avg
Panel avg: 90d · This submission: 60d
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 172
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K001058.
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
HORTMANN ECHOMASTER OAE ANALYZER
K994033 · Hortmann AG · Feb 2000
AUDIOSCREENER OAE
K000184 · Kedly, Inc. · Feb 2000
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K984547 · Resound Corp. · Mar 1999
K001058 · AUDIOSCREENER OAE + ABR
Download PDF FDA Summary Kedly, Inc.