510(k) Report

FDA applicant

Di-Chem, Inc.

Champlin, MN6 decisions1982–20222 recalls

FDA records 6 decisions for Di-Chem, Inc. (Champlin, MN) from 1982 to 2022: 6 510(k) clearances. Most are in product codes KPO (Dialysate Concentrate For Hemodialysis (Liquid…) and LIF (Dialyzer Reprocessing System). Its devices cite 7 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.

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 Di-Chem, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2017: 12022: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2025: 1, 1 Class I2026 (partial year): 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Di-Chem, 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?

  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)5decisions
  • LIFDialyzer Reprocessing System1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K012328Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate PowderDi-Chem, Inc. · 20021cites it

What has FDA decided for it lately?

  • K202508Hemo-Lyte C CartridgeDi-Chem, Inc. · 2022
  • K171015CitryteDi-Chem, Inc. · 2017
  • K012328Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate PowderDi-Chem, Inc. · 2002
  • K012547Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate SolutionDi-Chem, Inc. · 20021 Class I recall
  • K905217Formasure Test ReagentDi-Chem, Inc. · 1991
  • K823103Dialysate Additives-Powder/LiquidDi-Chem, Inc. · 1982

All 6 as Di-Chem, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K012547MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201Aug 5, 2026Class II
  • K012547MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X.…Apr 11, 2025Class I