510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895251Substantially Equivalent

Bard Intravaginal Stim. Kit W/(ives(tm))

C.R. Bard Inc, Covington GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895251 is the FDA 510(k) clearance record for BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)), a class II device, cleared for C.R. Bard, Inc. on under FDA product code KPN (Alarm, Conditioned Response Enuresis). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K895251.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KPN Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 8195 Industrial Blvd., Covington GA
Third party review
No

Clearances, product code KPN

Trailing 12 months

FDA records hold no clearances under product code KPN in the trailing twelve months.

FDA records show no clearances under product code KPN in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260