Cleared Traditional

K884046 - AUDIOSCAN(TM) REAL EAR MEASUREMENT SYST...

K884046 is an FDA 510(k) clearance for AUDIOSCAN(TM) REAL EAR MEASUREMENT SYST..., manufactured by Etymonic Design, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K884046 · Etymonic Design, Inc. · Ear, Nose, Throat device
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Feb 1989
Decision
140d
Days
Class 2
Risk

K884046 is an FDA 510(k) clearance for the AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Etymonic Design, Inc. (Dorchester, Ontario, CA). The FDA issued a Cleared decision on February 13, 1989 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - 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 Etymonic Design, Inc. devices

FDA 510(k) Submission Details - K884046

510(k) Number K884046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date February 13, 1989
Days to Decision 140 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 89d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETW Device Classification - Class 2, Special Controls

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
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 - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 10
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