Cleared Special

K162210 - touchTymp

K162210 is an FDA 510(k) clearance for touchTymp, manufactured by Maico Diagnostics GmbH. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Special 510(k) pathway after a 103-day FDA review.

K162210 · Maico Diagnostics GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
103d
Days
Class 2
Risk

K162210 is an FDA 510(k) clearance for the touchTymp. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Maico Diagnostics GmbH (Berlin, DE). The FDA issued a Cleared decision on November 16, 2016 after a review of 103 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Maico Diagnostics GmbH devices

FDA 510(k) Submission Details - K162210

510(k) Number K162210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2016
Decision Date November 16, 2016
Days to Decision 103 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 89d · This submission: 103d
Pathway characteristics
Modification to existing cleared device.

ETY Device Classification - Class 2, Special Controls

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 Peers - ETY Tester, Auditory Impedance

All 11
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K162210.
Hearing Healthcare Pro
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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