510(k) Report

FDA applicant

Medical Engineering and Development Institute

West Lafayette, IN6 decisions1989–19900 recalls

FDA records 6 decisions for Medical Engineering and Development Institute (West Lafayette, IN) from 1989 to 1990: 6 510(k) clearances. Most are in product codes GCC (Dilator, Catheter) and DRE (Dilator, Vessel, For Percutaneous…). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Medical Engineering and Development Institute since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Engineering and Development Institute 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?

  • GCCDilator, Catheter2decisions
  • DREDilator, Vessel, For Percutaneous Catheterization1decision
  • DYBIntroducer, Catheter1decision
  • GADRetractor1decision
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular1decision

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.

  • K902469Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute · 19903cite it

What has FDA decided for it lately?

  • K902477Workstation Femoral Intravascular Retrieval SetMedical Engineering and Development Institute · 1990
  • K902469Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute · 1990
  • K902502Byrd Stainless Steel DilatorMedical Engineering and Development Institute · 1990
  • K895030Life-Line (TM) Vascular Access SystemMedical Engineering and Development Institute · 1990
  • K893480Byrd Extractor SetMedical Engineering and Development Institute · 1989
  • K890820Locking Wire Guide StyletMedical Engineering and Development Institute · 1989

All 6 as Medical Engineering and Development Institute →