510(k) Report

FDA applicant

Dialysis Solutions, Inc.

Lincolnshire, IL1 decision2005–20050 recalls

FDA records 1 decision for Dialysis Solutions, Inc. (Lincolnshire, IL) in 2005: 1 510(k) clearance. All are in product code KPO (Dialysate Concentrate For Hemodialysis (Liquid…). 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 Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Dialysis”

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