510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191563Substantially Equivalent

FILTRAY 2G Disposable Water Filters

Aqua-Tools, Poissy, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191563 is the FDA 510(k) clearance record for FILTRAY 2G Disposable Water Filters, a class II device, cleared for Aqua-Tools on under FDA product code NHV (System, Water Purification, General Medical Use). FDA's definition for product code NHV reads: "The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not...". FDA records list one 510(k) clearance for Aqua-Tools. As of , FDA records show no recalls naming K191563.

Clearance record

Decision date
Received
(134 days to decision)
Product code
NHV System, Water Purification, General Medical Use
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Aqua-Tools 26, Rue Charles Edouard Jeanneret, Poissy, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHV

Trailing 12 months
1 clearance under product code NHV in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NHV, 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 20261
October 20260