510(k) Report

FDA applicant

Medical Device Intl., Inc.

Minnetonka, MN1 decision1996–19960 recalls

FDA records 1 decision for Medical Device Intl., Inc. (Minnetonka, MN) in 1996: 1 510(k) clearance. All are in product code EZL (Catheter, Retention Type, Balloon). Its devices cite 2 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Medical Device Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Device Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medical Device Intl., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EZLCatheter, Retention Type, Balloon1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K961697Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 19962cite it

What has FDA decided for it lately?

  • K961697Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 1996

The one decision as Medical Device Intl., Inc. →