510(k) Report

FDA applicant

Mri Manufacturing and Research, Inc.

Tuscon, AZ3 decisions1996–20090 recalls

FDA records 3 decisions for Mri Manufacturing and Research, Inc. (Tuscon, AZ) from 1996 to 2009: 3 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 3 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 Mri Manufacturing and Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mri Manufacturing and Research, 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?

  • EZLCatheter, Retention Type, Balloon2decisions
  • KNTTubes, Gastrointestinal (And Accessories)1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc. · 20091cites it

What has FDA decided for it lately?

  • K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc. · 2009
  • K982970Mri's All Silicone Irrigation 3-Way Foley CatheterMri Manufacturing and Research, Inc. · 1998
  • K944676Mri's All Silicone Foley CatheterMri Manufacturing and Research, Inc. · 1996

All 3 as Mri Manufacturing and Research, Inc. →