FDA applicant

Renal Systems, Inc.

Mchenry, IL35 decisions1977–19981 recall

FDA records 35 decisions for Renal Systems, Inc. (Mchenry, IL) from 1977 to 1998: 35 510(k) clearances. Most are in product codes FIQ (Cannula, A-V Shunt) and LIF (Dialyzer Reprocessing System). 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 Renal Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2021

2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Renal Systems, 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 “Renal”

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

Renal Solutions, Inc. 9 Renal Devices, Inc. 4 Renal Care Corp. 2 Renal Hygienics 1 Renal Scientific Service, Inc. 1 Renal Dynamics, Inc. 1 Renal Care Dialysis Solutions, S.A. DE C.V. 1

Renal Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Renal”