510(k) Report

FDA applicant

Island Medical

Fernandina Beach, FL2 decisions1989–19890 recalls

FDA records 2 decisions for Island Medical (Fernandina Beach, FL) in 1989: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and BSY (Catheters, Suction, Tracheobronchial). 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, general hospital panel, where it files most

How often FDA has decided Island Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Island Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Island Medical 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?

  • FPASet, Administration, Intravascular1decision
  • BSYCatheters, Suction, Tracheobronchial1decision

What has FDA decided for it lately?

  • K893120Kit, Intravenous Extension TubingIsland Medical · 1989
  • K893204MUC-XIsland Medical · 1989

All 2 as Island Medical →

Other applicant names beginning “Island”

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

Island Biosurgical, Inc. 4Island Dental Lab, Inc Dba Emerald Dental 1Island Critical Care Corp. 1Island Dressing, LLC 1