510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830994Substantially Equivalent

Redox Controller

St. Louis Univ. Medical Center, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830994 is the FDA 510(k) clearance record for REDOX CONTROLLER, a class II device, cleared for St. Louis Univ. Medical Center on under FDA product code KDN (System, Perfusion, Kidney). FDA records list one 510(k) clearance for St. Louis Univ. Medical Center. As of , FDA records show no recalls naming K830994.

Clearance record

Decision date
Received
(59 days to decision)
Product code
KDN System, Perfusion, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
St. Louis Univ. Medical Center 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KDN

Trailing 12 months
3 clearances under product code KDN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260