Cleared Special

K070312 - EARCHECK ACOUSTIC REFLECTOMETER

K070312 is an FDA 510(k) clearance for EARCHECK ACOUSTIC REFLECTOMETER, manufactured by Innovia Medical, LLC. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Special 510(k) pathway after a 29-day FDA review.

K070312 · Innovia Medical, LLC · Ear, Nose, Throat device
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Mar 2007
Decision
29d
Days
Class 2
Risk

K070312 is an FDA 510(k) clearance for the EARCHECK ACOUSTIC REFLECTOMETER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Innovia Medical, LLC (Littleton, US). The FDA issued a Cleared decision on March 2, 2007 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Innovia Medical, LLC devices

FDA 510(k) Submission Details - K070312

510(k) Number K070312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2007
Decision Date March 02, 2007
Days to Decision 29 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 90d · This submission: 29d
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 45
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