Cleared Traditional

K964216 - STARKEY TM-3

K964216 is the FDA 510(k) clearance for STARKEY TM-3 by Starkey Laboratories, Inc.. It is a Class 2 Ear, Nose, Throat device (product code KLW) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K964216 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
45d
Days
Class 2
Risk

K964216 is an FDA 510(k) clearance for the STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 6, 1996 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 K964216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1996
Decision Date December 06, 1996
Days to Decision 45 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 16
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K964216.
Tinnitus Sound Generator Module
K181586 · GN Hearing A/S · Jul 2018
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · Widex Hearing Aid Co., Inc. · Jun 2008
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · Starkey Laboratories, Inc. · Sep 2003
STARKEY TM AIR CONDUCTION TINNITUS MASKER
K963838 · Starkey Laboratories, Inc. · Nov 1996
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
K963995 · Starkey Laboratories, Inc. · Nov 1996
MODEL TM5 BEHIND EAR TINNITUS MASKER
K791790 · Starkey Laboratories, Inc. · Oct 1979