Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022978

FEI Number

3006582718

Entity Name

FORTUNE MEDICAL INSTRUMENT CORP.

City/State/Country

Taoyuan City, TW

Establishment Address

No. 256, Changchun 2nd Rd., Jhongli Dist., Taoyuan City 320, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

FORTUNE MEDICAL INSTRUMENT CORP. (Owner Number: 8022978)

Owner / Operator Contact Address

6 F., No. 29, Sec. 2, Jhongjheng E. Rd.,, Danshuei Dist,, New Taipei City, TW-TPE 251, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K022112

PMA Number

N/A

All Registered Proprietary Names

SILICONE SUCTION CATHETER Rystora® Skin Protector-Spray ALL SILICONE THORA "Fortune" Silicone Hematuria Catheter MEDICAL TUBE Silicone airway (laryngeal) Silicone Nasal Cannula SILICONE C.W.V. RESERVIOR Flexi-Seal® SIGNAL Fecal Management System Flexi-Seal Signal FMS Silicone Nasal Epistaxis Balloon Rystora® Silicone Scar Tape Rystora® Silicone Scar Sheet Rystora® Silicone Scar Gel SILICONE T T-Y DRAINAGE TUBE Y Rystora® Adhesive Remover- Spray ALL SILICONE SUPRAPUBIC CATHETER Flexi-Seal Signal FMS Zeolite Flexi-Seal® SIGNAL Fecal Management System DRAIN TUBE SILICONE VACUUM SUCTION SILICONE DRAIN CATHETER "Fortune" FixPad Silicone Vessel ID Loops OXYGEN TUBING STOMACH (GASTRIC) TUBING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	1988-11-17
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2020-05-12
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2006-01-30
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2025-03-27
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-03-27
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2006-01-30
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2006-12-19
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2006-01-30
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-03-22
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2015-09-22
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2006-01-30
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-10-15
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2013-01-17
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2011-10-13
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2010-01-24
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2020-05-12
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2006-01-30
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2024-08-19
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2006-01-30
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-10-15
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2006-03-24
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	Class 2	884.4340	2006-01-30
GBP	Catheter, Multiple Lumen	General, Plastic Surgery	Class 1	878.4200	2006-01-30
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2020-09-02
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-02-23
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2026-02-23
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-25
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2006-01-30
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2006-01-30

Official Correspondent

ABE WANG

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

FORTUNE MEDICAL INSTRUMENT CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022978. Last updated year: 2026. Please use registration number 8022978 when referencing this establishment in official correspondence.