510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013448Substantially Equivalent

Prismasate

Gambro Renal Products, Daytona Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013448 is the FDA 510(k) clearance record for PRISMASATE, a class II device, cleared for Gambro Renal Products on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list 37 510(k) clearances for Gambro Renal Products, from to . As of , FDA records show no recalls naming K013448.

Clearance record

Decision date
Received
(90 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
Gambro Renal Products 1845 Mason Ave., Daytona Beach FL
510(k) summary
Summary
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