510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K262353Substantially Equivalent

Btl-299-F

BTL Industries, Inc., Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(75 days to decision)
Product code
KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation
21 CFR 876.5320
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
BTL Industries, Inc. 362 Elm St., Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPI

Trailing 12 months
7 clearances under product code KPI in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20262
May 20262
June 20261
July 20260
August 20260
September 20261
October 20260