# Fortune Medical Instrument Corp.

- Location (FDA's records): Taipei Hsien, TW
- FDA decisions: 6 (1998–2003): 6 510(k) clearances
- Product codes: EZL (2), KOB (1), KNT (1), GCA (1), HDB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Mediplus, Ltd.: 2 (https://510kreport.com/company/mediplus)
- Well Lead Medical Co., Ltd.: 1 (https://510kreport.com/company/well-lead-medical)
- Urethrotech: 1 (https://510kreport.com/company/urethrotech)
- Seedings Life Science Ventures, LLC: 1 (https://510kreport.com/company/seedings-life-science-ventures)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Its most-cited devices
- K980919: All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter (1998), cited by 3
- K014002: All Silicone Supra-Pubia Catheter, Models 4880/4890 (2002), cited by 2
- K022112: Fortune All Silicone Stomach (Gastric) Tubes, Model 2020 (2003), cited by 1

## Recent decisions
- K022112: Fortune All Silicone Stomach (Gastric) Tubes, Model 2020 (Apr 3, 2003)
- K021193: Fortune Silicone Vacuum Suction, Model #1300 (Feb 12, 2003)
- K021142: All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865 (Oct 1, 2002)
- K014002: All Silicone Supra-Pubia Catheter, Models 4880/4890 (Mar 4, 2002)
- K980917: All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV Reservoir (May 27, 1998)
- K980919: All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter (Mar 31, 1998)

Source page: https://510kreport.com/company/fortune-medical-instrument