510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K071104Substantially Equivalent

Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-Up Pedi System

Flier'S Quality Water Systems, Inc., Byron Center MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071104 is the FDA 510(k) clearance record for ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM, a class II device, cleared for Flier'S Quality Water Systems, Inc. on under FDA product code FIP (Subsystem, Water Purification). FDA records list one 510(k) clearance for Flier'S Quality Water Systems, Inc. As of , FDA records show no recalls naming K071104.

Clearance record

Decision date
Received
(270 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Flier'S Quality Water Systems, Inc. 7425 Clyde Park Ave. SW, Byron Center MI
510(k) summary
Summary PDF
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