FJK · Class II · 21 CFR 876.5820

FDA Product Code FJK: Set, Tubing, Blood, With And Without Anti-regurgitation Valve

Leading manufacturers include Bain Medical Equipment (Guangzhou) Co., Ltd., Dimesol, Inc. and Jiangxi Sanxin Medtec Co., Ltd..

77
Total
77
Cleared
155d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 181d recently vs 154d historically

FDA 510(k) Cleared Set, Tubing, Blood, With And Without Anti-regurgitation Valve Devices (Product Code FJK)

77 devices
1–24 of 77
Cleared May 15, 2026
NovaLine Tubing Set for Hemodialysis (BL 124)
K252423
Bain Medical Equipment (Guangzhou) Co., Ltd.
Gastroenterology & Urology · 287d
Cleared Jan 16, 2026
VITAL Tubing Sets for Hemodialysis
K251341
Vital Healthcare Sdn. Bhd.
Gastroenterology & Urology · 261d
Cleared Oct 02, 2025
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
K251442
Ningbo Tianyi Medical Appliance Co., Ltd.
Gastroenterology & Urology · 146d
Cleared Dec 20, 2024
Moda-flx Hemodialysis System™ Cartridge (102121-001 )
K243607
Diality, Inc.
Gastroenterology & Urology · 29d
Cleared May 31, 2023
CombiSet Hemodialysis Blood Tubing Set
K213992
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 526d
Cleared Nov 26, 2021
Tablo Cartridge
K210782
Outset Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Sep 06, 2021
SANSIN Tubing Sets for Hemodialysis
K202796
Jiangxi Sanxin Medtec Co., Ltd.
Gastroenterology & Urology · 348d
Cleared Mar 10, 2021
NovaLine Tubing Sets for Hemodialysis
K201866
Bain Medical Equipment (Guangzhou) Co., Ltd.
Gastroenterology & Urology · 246d
Cleared Mar 30, 2018
Dimesol Tubing Sets for Hemodialysis
K171952
Dimesol, Inc.
Gastroenterology & Urology · 274d
Cleared Dec 17, 1993
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803
Baxter Healthcare Corp
Gastroenterology & Urology · 58d

About Product Code FJK - Regulatory Context

510(k) Submission Activity

77 total 510(k) submissions under product code FJK since 1977, with 77 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FJK Product Code

Recent submissions under FJK have taken an average of 181 days to reach a decision - up from 154 days historically. Manufacturers should account for longer review timelines in current project planning.

FJK devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →