Cleared Traditional

K183201 - Hearing Healthcare Pro

K183201 is the FDA 510(k) clearance for Hearing Healthcare Pro by Db Diagnostic Systems, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETY) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K183201 · Db Diagnostic Systems, Inc. · Ear, Nose, Throat device
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Mar 2019
Decision
107d
Days
Class 2
Risk

K183201 is an FDA 510(k) clearance for the Hearing Healthcare Pro. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Db Diagnostic Systems, Inc. (Weston, US). The FDA issued a Cleared decision on March 6, 2019 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - 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. Standard predicate reliance. 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 Db Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K183201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date March 06, 2019
Days to Decision 107 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
18d slower than avg
Panel avg: 89d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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 Consultant

MEDIcept, Inc.
Scott Blood

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ETY Tester, Auditory Impedance

All 10
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K183201.
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
K953161 · Maico Hearing Instruments, Inc. · Jul 1995
HANDTYMP
K923072 · Life-Tech Intl., Inc. · Mar 1993
AUTOMATIC TYMPANOMETER
K923073 · Life-Tech Intl., Inc. · Feb 1993
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · Maico Hearing Instruments, Inc. · Apr 1991
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · Storz Instrument Co. · Jun 1989
WELCH ALLYN TYMPANOMETER
K861516 · Welch Allyn, Inc. · Jun 1986