Cleared Special

Multiflex Tinnitus Technology (K201370) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201370 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
28d
Days
Class 2
Risk

K201370 is an FDA 510(k) clearance for the Multiflex Tinnitus Technology. 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 June 19, 2020 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K201370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2020
Decision Date June 19, 2020
Days to Decision 28 days
Submission Type Special
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
61d faster than avg
Panel avg: 89d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K201370.
Peace N Quiet (0.7.0)
K233435 · Pnq Health · Feb 2024
Tinearity G1 (6103)
K223694 · Duearity AB · Jun 2023
Tinnitogram Signal Generator
K221168 · Goldenear Company, Inc. · Feb 2023
SilentCloud
K221125 · Aureliym GmbH · Jan 2023
Tinnitus Sound Generator Module
K193303 · GN Hearing A/S · Feb 2020
Tinnitus Sound Generator Module
K180495 · GN Hearing A/S · Nov 2018