510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260614Substantially Equivalent

Tinnitus Therapy

Sivantos Pte Ltd, Erlangen, DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260614 is the FDA 510(k) clearance record for Tinnitus Therapy, a class II device, cleared for Sivantos GmbH on under FDA product code KLW (Masker, Tinnitus). FDA records list one 510(k) clearance for Sivantos GmbH. As of , FDA records show no recalls naming K260614.

Clearance record

Decision date
Received
(105 days to decision)
Product code
KLW Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Sivantos GmbH Henri-Dunant-Str. 100, Erlangen, DE
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