510(k) Report

FDA applicant

Renal Devices, Inc.

Mchenry, IL4 decisions1979–19810 recalls

FDA records 4 decisions for Renal Devices, Inc. (Mchenry, IL) from 1979 to 1981: 4 510(k) clearances. Most are in product codes FJI (Dialyzer, Capillary, Hollow Fiber) and FKQ (System, Dialysate Delivery, Central Multiple…). 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 Renal Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Renal Devices, 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?

  • FJIDialyzer, Capillary, Hollow Fiber2decisions
  • FKQSystem, Dialysate Delivery, Central Multiple Patient1decision
  • FKISet, Dialyzer Holder1decision

What has FDA decided for it lately?

  • K810612HemophronRenal Devices, Inc. · 1981
  • K801559Hollo Fiber DialyzerRenal Devices, Inc. · 1980
  • K802075Hollow Fiber Dialyzer HolderRenal Devices, Inc. · 1980
  • K790696Rdi-1 Hollow Fiber DialyzerRenal Devices, Inc. · 1979

All 4 as Renal Devices, Inc. →

Other applicant names beginning “Renal”

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

Renal Systems, Inc. 35Renal Solutions, Inc. 9Renal Care Corp. 2Renal Hygienics 1Renal Scientific Service, Inc. 1Renal Dynamics, Inc. 1Renal Care Dialysis Solutions, S.A. DE C.V. 1