510(k) Report

FDA applicant

Pure Water Solutions, Inc.

Englewood, CO2 decisions2000–20020 recalls

FDA records 2 decisions for Pure Water Solutions, Inc. (Englewood, CO) from 2000 to 2002: 2 510(k) clearances. 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 Pure Water Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pure Water Solutions, 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

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?

  • K011005Pure Water Solutions Central Water System for HemodialysisPure Water Solutions, Inc. · 2002
  • K994279Pure Water-CDS (Central Dialysis Solution)Pure Water Solutions, Inc. · 2000

All 2 as Pure Water Solutions, Inc. →

Other applicant names beginning “Pure”

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

Pure Water, Inc. 3Pure Co. 1