510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991916Substantially Equivalent

Virginia Water Systems' Water Purification System for Hemodialysis

Virginia Water Systems, Inc., Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991916 is the FDA 510(k) clearance record for VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS, a class II device, cleared for Virginia Water Systems, Inc. on under FDA product code FIP (Subsystem, Water Purification). FDA records list one 510(k) clearance for Virginia Water Systems, Inc. As of , FDA records show no recalls naming K991916.

Clearance record

Decision date
Received
(221 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Virginia Water Systems, Inc. 7433 Whitepine Rd., Richmond VA
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