510(k) Report

FDA applicant

Nordisk Infuser System

Walker, MI2 decisions1979–19860 recalls

FDA records 2 decisions for Nordisk Infuser System (Walker, MI) from 1979 to 1986: 2 510(k) clearances. Most are in product codes KSZ (System, Test, Automated Blood Grouping And…) and FRN (Pump, Infusion). 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, hematology panel, where it files most

How often FDA has decided Nordisk Infuser System’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nordisk Infuser System since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nordisk Infuser System 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?

  • KSZSystem, Test, Automated Blood Grouping And Antibody1decision
  • FRNPump, Infusion1decision

What has FDA decided for it lately?

  • K860492Nordisk Infuser System with Pre-Filled CartridgeNordisk Infuser System · 1986
  • K790282EldoncardNordisk Infuser System · 1979

All 2 as Nordisk Infuser System →