510(k) Report

FDA applicant

Med Institute, Inc.

West Lafayette, IN26 decisions1990–20002 recalls

FDA records 26 decisions for Med Institute, Inc. (West Lafayette, IN) from 1990 to 2000: 26 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and DRE (Dilator, Vessel, For Percutaneous…). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are 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 Med Institute, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med Institute, Inc. since 2007.

Recalls per year

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Med Institute, 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?

  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular17decisions
  • DREDilator, Vessel, For Percutaneous Catheterization2decisions
  • GCCDilator, Catheter2decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision
  • MQRStent, Colonic, Metallic, Expandable1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision

Also: FMI (1), ITX (1).

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K990034Wilson-Cook Colonic Z-StentMed Institute, Inc. · 20001cites it
  • K945586Flexible Dilating SheathMed Institute, Inc. · 19971cites it
  • K964001Swartz Doppler Flow Probe and Monitor SystemMed Institute, Inc. · 19981cites it

What has FDA decided for it lately?

  • K990034Wilson-Cook Colonic Z-StentMed Institute, Inc. · 2000
  • K982507Mini Polyurethane CatheterMed Institute, Inc. · 1998
  • K981061Intravascular Retrieval DeviceMed Institute, Inc. · 1998
  • K964001Swartz Doppler Flow Probe and Monitor SystemMed Institute, Inc. · 1998
  • K971140Vital-Port Infusion PalMed Institute, Inc. · 1997
  • K970442Target Vital-Port Vascular Access SystemMed Institute, Inc. · 1997
  • K945586Flexible Dilating SheathMed Institute, Inc. · 1997
  • K960698Non-Coring NeedleMed Institute, Inc. · 1996

All 26 as Med Institute, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K924748Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheterApr 24, 2008
  • K924748Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheterApr 24, 2008