510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K153384Substantially Equivalent

Low Potassium Dextran Solution with Tris Diluent

United Therapeutics Corporation, Research Triangle Park NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153384 is the FDA 510(k) clearance record for Low Potassium Dextran Solution with Tris Diluent, a class II device, cleared for United Therapeutics Corporation on under FDA product code KDN (System, Perfusion, Kidney). FDA records list one 510(k) clearance for United Therapeutics Corporation. As of , FDA records show no recalls naming K153384.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KDN System, Perfusion, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United Therapeutics Corporation 55 T.W. Alexander Dr., P.O. Box 14186, Research Triangle Park NC
510(k) summary
Summary PDF
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