510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983512Substantially Equivalent

Water Treatment System for Hemodialysis

Water Vault, Inc., Nashville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983512 is the FDA 510(k) clearance record for WATER TREATMENT SYSTEM FOR HEMODIALYSIS, a class II device, cleared for Water Vault, Inc. on under FDA product code FIP (Subsystem, Water Purification). FDA records list one 510(k) clearance for Water Vault, Inc. As of , FDA records show no recalls naming K983512.

Clearance record

Decision date
Received
(203 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Water Vault, Inc. 2003 Blair Blvd., Nashville TN
510(k) summary
Summary
Third party review
No

Clearances, product code FIP

Trailing 12 months
1 clearance under product code FIP in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FIP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260