510(k) Report

FDA applicant

Dialysis Systems, Inc.

Walker, MI2 decisions1982–20040 recalls

FDA records 2 decisions for Dialysis Systems, Inc. (Walker, MI) from 1982 to 2004: 2 510(k) clearances. Most are in product codes KOC (Accessories, Blood Circuit, Hemodialysis) and FIN (Tank, Holding, Dialysis). 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 Dialysis Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dialysis Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dialysis Systems, 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?

  • KOCAccessories, Blood Circuit, Hemodialysis1decision
  • FINTank, Holding, Dialysis1decision

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?

  • K030366Bicard Mixing SystemDialysis Systems, Inc. · 2004
  • K822244NephrosolDialysis Systems, Inc. · 1982

All 2 as Dialysis Systems, Inc. →

Other applicant names beginning “Dialysis”

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

Dialysis Services, Inc. 2Dialysis Products, Inc. 2Dialysis Solutions, Inc. 1Dialysis Medical Solutions, LLC 1Dialysis Clinic, Inc. 1