Cleared Traditional

K904755 - ACOUSTIQ LISTENING DEVICE

K904755 is an FDA 510(k) clearance for ACOUSTIQ LISTENING DEVICE, manufactured by Krueger Laboratories. The device is a Class 2 Ear, Nose, Throat device with product code LZI cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K904755 · Krueger Laboratories · Ear, Nose, Throat device
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Jan 1991
Decision
102d
Days
Class 2
Risk

K904755 is an FDA 510(k) clearance for the ACOUSTIQ LISTENING DEVICE. Classified as Device, Assistive Listening (product code LZI), Class II - Special Controls.

Submitted by Krueger Laboratories (Tempe, US). The FDA issued a Cleared decision on January 29, 1991 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3320 - 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 Krueger Laboratories devices

FDA 510(k) Submission Details - K904755

510(k) Number K904755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1990
Decision Date January 29, 1991
Days to Decision 102 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
13d slower than avg
Panel avg: 89d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZI Device Classification - Class 2, Special Controls

Product Code LZI Device, Assistive Listening
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3320
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.