Cleared Traditional

K940567 - MODEL#1550 MARSONA(R) TINNITUS MASKER

K940567 is an FDA 510(k) clearance for MODEL#1550 MARSONA TINNITUS MASKER, manufactured by Marpac, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K940567 · Marpac, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
148d
Days
Class 2
Risk

K940567 is an FDA 510(k) clearance for the MODEL#1550 MARSONA(R) TINNITUS MASKER. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Marpac, Inc. (Wilmington, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 148 days - within the typical 510(k) review window.

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: 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 Marpac, Inc. devices

FDA 510(k) Submission Details - K940567

510(k) Number K940567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date July 06, 1994
Days to Decision 148 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 90d · This submission: 148d
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 39
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K940567.
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