Cleared Traditional

K053216 - HEARID WIDEBAND MIDDLE EAR POWER ANALYZER

K053216 is an FDA 510(k) clearance for HEARID WIDEBAND MIDDLE EAR POWER ANALYZER, manufactured by Mimosa Acoustics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K053216 · Mimosa Acoustics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
85d
Days
Class 2
Risk

K053216 is an FDA 510(k) clearance for the HEARID WIDEBAND MIDDLE EAR POWER ANALYZER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Mimosa Acoustics, Inc. (Champaign, US). The FDA issued a Cleared decision on February 10, 2006 after a review of 85 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.

View all Mimosa Acoustics, Inc. devices

FDA 510(k) Submission Details - K053216

510(k) Number K053216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2005
Decision Date February 10, 2006
Days to Decision 85 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
5d faster than avg
Panel avg: 90d · This submission: 85d
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 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K053216.
PILOT TEST OR DETECTIVE AUDIOMETERS
K060883 · Interacoustics A/S · Jun 2006
MODEL MI 44 TYMPANOMETER
K060885 · Maico-Diagnostics · Jun 2006
DPOAE20 , ECLIPSE
K060539 · Interacoustics A/S, Assens · May 2006
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
K052562 · Interacoustics AS · Dec 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K043219 · Interacoustics AS · Feb 2005
BIO-LOGIC INSERT EARPHONES
K031352 · Bio-Logic Systems Corp. · Jul 2003