510(k) Report

FDA applicant

American Medical Products, Inc.

Mchenry, IL30 decisions1978–19921 recall

FDA records 30 decisions for American Medical Products, Inc. (Mchenry, IL) from 1978 to 1992: 30 510(k) clearances. Most are in product codes FKX (System, Peritoneal, Automatic Delivery) and KDJ (Set, Administration, For Peritoneal Dialysis…). 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 American Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Medical Products, 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?

  • FKXSystem, Peritoneal, Automatic Delivery11decisions
  • KDJSet, Administration, For Peritoneal Dialysis, Disposable7decisions
  • KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal3decisions
  • FRNPump, Infusion2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • DSKComputer, Blood-Pressure1decision

Also: FJS (1), KNX (1), FKK (1), KRH (1), JHI (1).

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K811986The Amp 80/2 Pediatric Cycler SystemAmerican Medical Products, Inc. · 19811cites it
  • K862221E-Z CleanAmerican Medical Products, Inc. · 19861cites it
  • K822549CCPD Cycler Set W/5 Pronged Safe LockAmerican Medical Products, Inc. · 19821cites it

What has FDA decided for it lately?

  • K922290Single-Step Pregnancy, HCG TestAmerican Medical Products, Inc. · 1992
  • K862221E-Z CleanAmerican Medical Products, Inc. · 1986
  • K861251Amp Closed Urinary Drainage Bag, 1011 & 1011NAmerican Medical Products, Inc. · 1986
  • K830881Ampercide Disinfectant Accessory to -American Medical Products, Inc. · 1983
  • K823827Amp 80/2 Outflow Monitor ModificationAmerican Medical Products, Inc. · 1983
  • K822544Safe Lock Sealing Cap LAmerican Medical Products, Inc. · 1982
  • K822546Safe Lock Sealing CapsAmerican Medical Products, Inc. · 1982
  • K822543Capd Safe Lock Transfer SetAmerican Medical Products, Inc. · 1982

All 30 as American Medical Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K822550Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female…Sep 20, 2004