510(k) Report

FDA applicant

Zyzatech Water Systems, Inc.

Kent, WA1 decision1997–19970 recalls

FDA records 1 decision for Zyzatech Water Systems, Inc. (Kent, WA) in 1997: 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 Zyzatech Water Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zyzatech Water Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zyzatech Water 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 8 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.

  • K964539Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse…Zyzatech Water Systems, Inc. · 19978cite it

What has FDA decided for it lately?

  • K964539Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse…Zyzatech Water Systems, Inc. · 1997

The one decision as Zyzatech Water Systems, Inc. →