510(k) Report

FDA applicant

Norfolk Medical

Skokie, IL4 decisions1991–20150 recalls

FDA records 4 decisions for Norfolk Medical (Skokie, IL) from 1991 to 2015: 4 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 11 predicates, 0 of them its own earlier devices. 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 Norfolk Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 12015: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Norfolk 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?

  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 20111cites it

What has FDA decided for it lately?

  • K151341Turbo High-Flow Non-coring NeedleNorfolk Medical · 2015
  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
  • K911067Norcath Vascular Access CathetersNorfolk Medical · 1991
  • K905646Omegaport Subcutaneously Implanted Drug DeliveryNorfolk Medical · 1991

All 4 as Norfolk Medical →

Other applicant names beginning “Norfolk”

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

Norfolk Medical Products, Inc. 20Norfolk Scientific, Inc. 7