Cleared Traditional

K981460 - CUB DIS II DPOAE MEASUREMENT SYSTEM

K981460 is an FDA 510(k) clearance for CUB DIS II DPOAE MEASUREMENT SYSTEM, 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 27-day FDA review.

K981460 · Mimosa Acoustics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
27d
Days
Class 2
Risk

K981460 is an FDA 510(k) clearance for the CUB DIS II DPOAE MEASUREMENT SYSTEM. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Mimosa Acoustics, Inc. (Mountainside, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 27 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 - K981460

510(k) Number K981460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1998
Decision Date May 20, 1998
Days to Decision 27 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
63d faster than avg
Panel avg: 90d · This submission: 27d
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 K981460.
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
K982249 · Idem (Int'L Dist. of Electronics For Medicine) · Aug 1998
OTO WIZZARD
K981511 · Medrx, Inc. · Jul 1998
CCA-200
K981439 · Benson Medical Instruments Co. · Jun 1998
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
K981327 · Idem (Int'L Dist. of Electronics For Medicine) · May 1998
MAICO MA53
K981142 · Bernafon-Maico, Inc. · Apr 1998
HORTMANN AMDIS-OAE OAE ANALYZER
K980505 · Hortmann AG · Apr 1998