Cleared Traditional

K040330 - QUIESCENCE

K040330 is an FDA 510(k) clearance for QUIESCENCE, manufactured by Spectral Visualization & Development, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K040330 · Spectral Visualization & Development, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
61d
Days
Class 2
Risk

K040330 is an FDA 510(k) clearance for the QUIESCENCE. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Spectral Visualization & Development, Inc. (Fredericton,New Brunswick, CA). The FDA issued a Cleared decision on April 12, 2004 after a review of 61 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.

FDA 510(k) Submission Details - K040330

510(k) Number K040330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2004
Decision Date April 12, 2004
Days to Decision 61 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
29d faster than avg
Panel avg: 90d · This submission: 61d
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 70
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K040330.
TINNITUS PHASE-OUT
K061111 · Tinnitus Control, Inc. · May 2006
NEUROMONICS TINNITUS TREATMENT
K043274 · Neuromonics Pty, Ltd. · Jan 2005
REFUGE SOUND GENERATOR
K041302 · Micro-Ear Technology, Inc. · Jul 2004
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · Starkey Laboratories, Inc. · Sep 2003
TINNITUS RX
K031624 · Tinnitus Control, Inc. · Jul 2003
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
K030791 · Tinnitech, Ltd. · Apr 2003
K040330 · QUIESCENCE
Download PDF FDA Summary Spectral Visualizatio…