510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051031Substantially Equivalent

Ameriwater Solution Mix and Distribution System for Hemodialysis

AmeriWater LLC., Dayton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051031 is the FDA 510(k) clearance record for AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS, a class II device, cleared for Ameriwater on under FDA product code FIN (Tank, Holding, Dialysis). FDA records list 12 510(k) clearances for Ameriwater, from to . As of , FDA records show no recalls naming K051031.

Clearance record

Decision date
Received
(259 days to decision)
Product code
FIN Tank, Holding, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ameriwater 1257 Stanley Ave., Dayton OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FIN

Trailing 12 months

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

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