510(k) Report

FDA applicant

Flier'S Quality Water Systems, Inc.

Byron Center, MI1 decision2008–20080 recalls

FDA records 1 decision for Flier'S Quality Water Systems, Inc. (Byron Center, MI) in 2008: 1 510(k) clearance. All are in product code FIP (Subsystem, Water Purification). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Flier'S Quality Water Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Flier'S Quality Water Systems, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FIPSubsystem, Water Purification1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K071104Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi SystemFlier'S Quality Water Systems, Inc. · 2008

The one decision as Flier'S Quality Water Systems, Inc. →