510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K940206Substantially Equivalent

Bard Urine Collection Products Modification

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

K940206 is the FDA 510(k) clearance record for BARD URINE COLLECTION PRODUCTS MODIFICATION, a class II device, cleared for C.R. Bard, Inc. on under FDA product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K940206.

Clearance record

Decision date
Received
(245 days to decision)
Product code
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 8195 Industrial Blvd., Covington GA
510(k) summary
Summary
Third party review
No

Clearances, product code KNX

Trailing 12 months

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

FDA records show no clearances under product code KNX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNX, 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