Cleared Traditional

MODEL TM5 BEHIND EAR TINNITUS MASKER (K791790) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K791790 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Oct 1979
Decision
45d
Days
Class 2
Risk

K791790 is an FDA 510(k) clearance for the MODEL TM5 BEHIND EAR TINNITUS MASKER. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K791790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1979
Decision Date October 26, 1979
Days to Decision 45 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
44d faster than avg
Panel avg: 89d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
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 - KLW Masker, Tinnitus

All 75
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K791790.
Peace N Quiet (0.7.0)
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SilentCloud
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Multiflex Tinnitus Technology
K201370 · Starkey Laboratories, Inc. · Jun 2020
Tinnitus Sound Generator Module
K193303 · GN Hearing A/S · Feb 2020