510(k) Report

FDA applicant

Hydropure Systems, Inc.

Orlando, FL1 decision2003–20030 recalls

FDA records 1 decision for Hydropure Systems, Inc. (Orlando, FL) in 2003: 1 510(k) clearance. All are in product code FIP (Subsystem, Water Purification). 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 Hydropure Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hydropure Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hydropure Systems, Inc. by year, 2007–2026Sources: 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

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022747Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi SystemHydropure Systems, Inc. · 20032cite it

What has FDA decided for it lately?

  • K022747Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi SystemHydropure Systems, Inc. · 2003

The one decision as Hydropure Systems, Inc. →