510(k) Report

FDA applicant

Isopure, Corp.

Simpsonville, KY5 decisions2000–20205 recalls

FDA records 5 decisions for Isopure, Corp. (Simpsonville, KY) from 2000 to 2020: 5 510(k) clearances. Most are in product codes FIP (Subsystem, Water Purification) and KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Its devices cite 4 predicates, 0 of them its own earlier devices. 5 recalls are 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 Isopure, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 22020: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2022

2011: 12019: 22022: 2
2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Isopure, Corp. 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
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)2decisions
  • FINTank, Holding, Dialysis1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K041163Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 SeriesIsopure, Corp. · 20044cite it
  • K993200MD 420/440/460/470/480/490Isopure, Corp. · 20001cites it
  • K191093Isopure Dry Acid Dissolution SystemIsopure, Corp. · 20201cites it

What has FDA decided for it lately?

  • K191093Isopure Dry Acid Dissolution SystemIsopure, Corp. · 2020
  • K120005ACDSIsopure, Corp. · 20122 recalls
  • K112427Bicarb Mixing and Distribution SystemIsopure, Corp. · 20122 recalls
  • K041163Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 SeriesIsopure, Corp. · 20041 recall
  • K993200MD 420/440/460/470/480/490Isopure, Corp. · 2000

All 5 as Isopure, Corp. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K120005Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate…Jul 26, 2022Class II
  • K112427Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)Apr 28, 2022Class II
  • K120005Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish…Apr 19, 2019Class II
  • K112427Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish…Apr 19, 2019Class II
  • K041163Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle.…Oct 24, 2011