510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830291Substantially Equivalent

Wak Wearable Artificial Kidney

Wak-Utah, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830291 is the FDA 510(k) clearance record for WAK WEARABLE ARTIFICIAL KIDNEY, a class II device, cleared for Wak-Utah on under FDA product code KOC (Accessories, Blood Circuit, Hemodialysis). FDA records list one 510(k) clearance for Wak-Utah. As of , FDA records show no recalls naming K830291.

Clearance record

Decision date
Received
(61 days to decision)
Product code
KOC Accessories, Blood Circuit, Hemodialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Wak-Utah 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KOC

Trailing 12 months

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

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