Cleared Traditional

K802750 - NUVOX BEDSIDE TINNITUS MASKER

K802750 is an FDA 510(k) clearance for NUVOX BEDSIDE TINNITUS MASKER, manufactured by Hal-Hen Co., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K802750 · Hal-Hen Co., Inc. · Ear, Nose, Throat device
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Dec 1980
Decision
57d
Days
Class 2
Risk

K802750 is an FDA 510(k) clearance for the NUVOX BEDSIDE TINNITUS MASKER. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Hal-Hen Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980 after a review of 57 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 Hal-Hen Co., Inc. devices

FDA 510(k) Submission Details - K802750

510(k) Number K802750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date December 31, 1980
Days to Decision 57 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
32d faster than avg
Panel avg: 89d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

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 22
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K802750.
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · Starkey Laboratories, Inc. · Dec 1996
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
MINUET MASKER
K800784 · Beltone Electronics Corp. · Apr 1980
MODEL TM5 BEHIND EAR TINNITUS MASKER
K791790 · Starkey Laboratories, Inc. · Oct 1979
HEARING AID, MODEL MA-1
K791142 · Starkey Laboratories, Inc. · Sep 1979