510(k) Report

FDA applicant

Pure Water, Inc.

Anderson, SC3 decisions2000–20001 recall

FDA records 3 decisions for Pure Water, Inc. (Anderson, SC) in 2000: 3 510(k) clearances. Most are in product codes FIN (Tank, Holding, Dialysis) and FIP (Subsystem, Water Purification). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pure Water, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pure Water, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FINTank, Holding, Dialysis2decisions
  • FIPSubsystem, Water Purification1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K993058Pure Water Inc's Acidified Storage and Distribution System with Optional Remote FillPure Water, Inc. · 20001cites it
  • K993272Pure Water, Inc.'S Bicarb Mix, Storage and Distribution SystemPure Water, Inc. · 20001cites it

What has FDA decided for it lately?

  • K993272Pure Water, Inc.'S Bicarb Mix, Storage and Distribution SystemPure Water, Inc. · 20001 recall
  • K993058Pure Water Inc's Acidified Storage and Distribution System with Optional Remote FillPure Water, Inc. · 2000
  • K992786Pure Water, Inc.'S Water Purification SystemsPure Water, Inc. · 2000

All 3 as Pure Water, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K993272Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial…May 19, 2011

Other applicant names beginning “Pure”

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

Pure Water Solutions, Inc. 2Pure Co. 1