510(k) Report

FDA applicant

Fortune Medical Instrument Corp.

Taipei Hsien, TW6 decisions1998–20030 recalls

FDA records 6 decisions for Fortune Medical Instrument Corp. (Taipei Hsien, TW) from 1998 to 2003: 6 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and KOB (Catheter, Suprapubic (And Accessories)). 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 Fortune Medical Instrument Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fortune Medical Instrument Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fortune Medical Instrument Corp. 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
  • KOBCatheter, Suprapubic (And Accessories)1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast…1decision
  • HDBExtractor, Vacuum, Fetal1decision

Who builds on its devices?

Later devices cite its devices 6 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.

  • K980919All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton CatheterFortune Medical Instrument Corp. · 19983cite it
  • K014002All Silicone Supra-Pubia Catheter, Models 4880/4890Fortune Medical Instrument Corp. · 20022cite it
  • K022112Fortune All Silicone Stomach (Gastric) Tubes, Model 2020Fortune Medical Instrument Corp. · 20031cites it

What has FDA decided for it lately?

  • K022112Fortune All Silicone Stomach (Gastric) Tubes, Model 2020Fortune Medical Instrument Corp. · 2003
  • K021193Fortune Silicone Vacuum Suction, Model #1300Fortune Medical Instrument Corp. · 2003
  • K021142All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865Fortune Medical Instrument Corp. · 2002
  • K014002All Silicone Supra-Pubia Catheter, Models 4880/4890Fortune Medical Instrument Corp. · 2002
  • K980917All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV ReservoirFortune Medical Instrument Corp. · 1998
  • K980919All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton CatheterFortune Medical Instrument Corp. · 1998

All 6 as Fortune Medical Instrument Corp. →