Cleared Traditional

K934342 - GLASER RT450 HEARING AID TEST AND ANALY...

K934342 is an FDA 510(k) clearance for GLASER RT450 HEARING AID TEST AND ANALY..., manufactured by Glaser Instruments AG. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K934342 · Glaser Instruments AG · Ear, Nose, Throat device
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Jan 1994
Decision
136d
Days
Class 2
Risk

K934342 is an FDA 510(k) clearance for the GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Glaser Instruments AG (Switzerland, CH). The FDA issued a Cleared decision on January 21, 1994 after a review of 136 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 Glaser Instruments AG devices

FDA 510(k) Submission Details - K934342

510(k) Number K934342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date January 21, 1994
Days to Decision 136 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 89d · This submission: 136d
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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