Cleared Traditional

K931325 - OTOACOUSTIC EMISSIONS UNIT CELESTA 503

K931325 is an FDA 510(k) clearance for OTOACOUSTIC EMISSIONS UNIT CELESTA 503, manufactured by Madsen Electronics (Canada) , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K931325 · Madsen Electronics (Canada) , Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
339d
Days
Class 2
Risk

K931325 is an FDA 510(k) clearance for the OTOACOUSTIC EMISSIONS UNIT CELESTA 503. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Madsen Electronics (Canada) , Ltd. (Minnetonka, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Madsen Electronics (Canada) , Ltd. devices

FDA 510(k) Submission Details - K931325

510(k) Number K931325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date February 18, 1994
Days to Decision 339 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
249d slower than avg
Panel avg: 90d · This submission: 339d
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 130
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K931325.
AUDIO EXPERT AUDIOMETER
K942716 · Beltone Electronics Corp. · Sep 1994
KS 5 - CLINICAL AUDIOMETER
K931322 · Maico Hearing Instruments, Inc. · Aug 1994
BELTONE SERIES 100 AUDIOMETERS
K940216 · Beltone Electronics Corp. · Jul 1994
ODYSSEY CLINICAL AUDIOMETER
K935348 · Qualitone · Feb 1994
SELECTOR SL 01
K933220 · Futuremed Div. of Future Impex Corp. · Nov 1993
ORBITER 922 CLINICAL AUDIOMETER
K931324 · Madsen Electronics (Canada) , Ltd. · Nov 1993