510(k) Report

FDA applicant

Bellhouse Medical, Inc.

Lake Elmo, MN3 decisions1986–19910 recalls

FDA records 3 decisions for Bellhouse Medical, Inc. (Lake Elmo, MN) from 1986 to 1991: 3 510(k) clearances. Most are in product codes FKX (System, Peritoneal, Automatic Delivery) and KGX (Tape And Bandage, Adhesive). 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 Bellhouse Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bellhouse Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bellhouse Medical, 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 Delivery1decision
  • KGXTape And Bandage, Adhesive1decision
  • JOZSystem, Automated Platelet Aggregation1decision

What has FDA decided for it lately?

  • K905022Aqua-Gard Waterproof Wound PatchBellhouse Medical, Inc. · 1991
  • K901228Multi-StripBellhouse Medical, Inc. · 1990
  • K862302Blood Platelet Assay Method & ApparatusBellhouse Medical, Inc. · 1986

All 3 as Bellhouse Medical, Inc. →