510(k) Report

FDA applicant

Diamed Division Ill. Tool Works, Inc.

Mchenry, IL7 decisions1978–19862 recalls

FDA records 7 decisions for Diamed Division Ill. Tool Works, Inc. (Mchenry, IL) from 1978 to 1986: 7 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and KNX (Collector, Urine, (And Accessories) For…). 2 recalls are 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 Diamed Division Ill. Tool Works, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diamed Division Ill. Tool Works, Inc. since 2007.

Recalls per year

1in 2026

2021: 12026 (partial year): 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Diamed Division Ill. Tool Works, 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?

  • KODCatheter, Urological4decisions
  • KNXCollector, Urine, (And Accessories) For Indwelling Catheter2decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

What has FDA decided for it lately?

  • K854953Diamed Models 600, 900, 960, 964Diamed Division Ill. Tool Works, Inc. · 1986
  • K823450Female External Urinary ApplianceDiamed Division Ill. Tool Works, Inc. · 1982
  • K812281Touchless Home-CathDiamed Division Ill. Tool Works, Inc. · 1981
  • K802665Touchless Clean-CathDiamed Division Ill. Tool Works, Inc. · 19802 recalls
  • K802664Urinary Drainage UntDiamed Division Ill. Tool Works, Inc. · 1980
  • K790728Touchless TM Foley Catheter KitDiamed Division Ill. Tool Works, Inc. · 1979
  • K760897Sterile Urethral Catheter KitDiamed Division Ill. Tool Works, Inc. · 1978

All 7 as Diamed Division Ill. Tool Works, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K000723Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF…Jun 25, 2026Class II
  • K802665Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) -…Jan 11, 2021Class II