510(k) Report

FDA applicant

Water Pure, Inc.

Louisville, KY2 decisions1986–19870 recalls

FDA records 2 decisions for Water Pure, Inc. (Louisville, KY) from 1986 to 1987: 2 510(k) clearances. 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 Water Pure, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Water Pure, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Water Pure, 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 Purification2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K873487HD-400-a/B/C Hemodialysis Systems & AccessoriesWater Pure, Inc. · 19871cites it

What has FDA decided for it lately?

  • K873487HD-400-a/B/C Hemodialysis Systems & AccessoriesWater Pure, Inc. · 1987
  • K863720HD-100 Hemodialysis Systems and AccessoriesWater Pure, Inc. · 1986

All 2 as Water Pure, Inc. →

Other applicant names beginning “Water”

FDA records each applicant name separately; these may or may not be the same firm.

Water-Jel Technologies, Inc. 2Water Solution Technologies 1The Water Carriage Co., Inc. 1Water Vault, Inc. 1Water & Power Technologies, Inc. 1