510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K852955Substantially Equivalent

Hemod Conce of Var Formu & Lipuid Hemod Conce Add

Renalchem, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852955 is the FDA 510(k) clearance record for HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD, a class II device, cleared for Renalchem, Inc. on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list one 510(k) clearance for Renalchem, Inc. As of , FDA records show no recalls naming K852955.

Clearance record

Decision date
Received
(209 days to decision)
Product code
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Renalchem, Inc. 401 Civic Center Dr., Santa Ana CA
Third party review
No

Clearances, product code KPO

Trailing 12 months
2 clearances under product code KPO 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 KPO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260