510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K040330Substantially Equivalent

Quiescence

Spectral Visualization & Development, Inc., Fredericton,New Brunswick, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040330 is the FDA 510(k) clearance record for QUIESCENCE, a class II device, cleared for Spectral Visualization & Development, Inc. on under FDA product code KLW (Masker, Tinnitus). FDA records list one 510(k) clearance for Spectral Visualization & Development, Inc. As of , FDA records show no recalls naming K040330.

Clearance record

Decision date
Received
(61 days to decision)
Product code
KLW Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Spectral Visualization & Development, Inc. 921 College Hill Rd., Fredericton,New Brunswick, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLW

Trailing 12 months
2 clearances under product code KLW in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260