510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822361Substantially Equivalent

Dianeal Solution Exchange Device #5C4193

Travenol Laboratories, S.A., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822361 is the FDA 510(k) clearance record for DIANEAL SOLUTION EXCHANGE DEVICE #5C4193, a class II device, cleared for Travenol Laboratories, S.A. on under FDA product code FKX (System, Peritoneal, Automatic Delivery). FDA records list 206 510(k) clearances for Travenol Laboratories, S.A., from to . As of , FDA records show no recalls naming K822361.

Clearance record

Decision date
Received
(10 days to decision)
Product code
FKX System, Peritoneal, Automatic Delivery
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Travenol Laboratories, S.A. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FKX

Trailing 12 months

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

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