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Quiescence

by Spectral Visualization & Development, Inc.

510(k) K040330

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040330 Date12 Apr 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KLW
Device Class
Class II
Regulation
21 CFR Part 874.3400
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Quiescence device is a Tinnitus Masker, classified as a Class II medical device under regulation number 874.3400. It is substantially equivalent to a predicate device and was cleared through the traditional 510(k) pathway.

Manufactured by Spectral Visualization & Development, Inc., the device is identified by product code KLW and K-number K040330. It is authorized for distribution in Canada and the United States, with the manufacturer located in Fredericton, New Brunswick.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Quiescence device used for?

    The Quiescence device is a Tinnitus Masker, designed to generate sound that helps mask or reduce the perception of tinnitus, providing auditory relief for individuals experiencing ringing or buzzing in the ears.

  • How is the Quiescence device supplied and is it reusable?

    The device is supplied as a finished medical device intended for repeated use; however, specific reuse instructions, cleaning protocols, or single-use limitations are not detailed in the provided data, so users should consult the manufacturer’s labeling for guidance on handling and durability.

  • What regulatory pathway was used for the Quiescence device and what is its classification?

    The Quiescence device was cleared through the traditional 510(k) pathway as a Class II medical device under regulation number 874.3400, determined to be substantially equivalent to a predicate device, with product code KLW and K-number K040330.