Panels › Gastroenterology, Urology › Product code FJK · Class 2
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Regulation 876.5820
2510(k)s in 12 months (77 all time)
7recalls in 12 months (36 all time)
35recalls that name a 510(k)
Top companies in FJK
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2026 | K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FJK |
| Jan 16, 2026 | K251341 | VITAL Tubing Sets for Hemodialysis Vital Healthcare Sdn. Bhd., MY | FJK |
| Oct 2, 2025 | K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) Ningbo Tianyi Medical Appliance Co., Ltd., CN | FJK |
| Dec 20, 2024 | K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 ) Diality, Inc. | FJK |
| May 31, 2023 | K213992 | CombiSet Hemodialysis Blood Tubing Set Fresenius Medical Care Renal Therapies Group, LLC | FJK |
| Nov 26, 2021 | K210782 | Tablo Cartridge Outset Medical, Inc. | FJK |
| Sep 6, 2021 | K202796 | SANSIN Tubing Sets for Hemodialysis Jiangxi Sanxin Medtec Co., Ltd., CN | FJK |
| Mar 10, 2021 | K201866 | NovaLine Tubing Sets for Hemodialysis Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FJK |
| Mar 30, 2018 | K171952 | Dimesol Tubing Sets for Hemodialysis Dimesol, Inc. | FJK |
| Jun 16, 2017 | K161582 | DORA Tubing Sets for Hemodialysis Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FJK |
| Feb 24, 2016 | K150304 | Oxyless Blood Tubing Set Oxyless, Ltd., GB | FJK |
| Sep 11, 2014 | K140841 | TABLO CARTRIDGE Home Dialysis Plus | FJK |
| Sep 28, 2012 | K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET Nipro Medical Corporation | FJK |
| Jun 15, 2012 | K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS Fresenius Medical Care North America, Design Cente | FJK |
| Nov 3, 2010 | K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 Gambro Renal Products, Inc. | FJK |
| Feb 10, 2009 | K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) Nxstage Medical, Inc. | FJK |
| Jul 18, 2008 | K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) Nxstage Medical, Inc. | FJK |
| Oct 12, 2007 | K070414 | GAMBRO CARTRIDGE BLOOD SETS Gambro Renal Products | FJK |
| Oct 4, 2007 | K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 Nipro Medical Corp. | FJK |
| Mar 23, 2007 | K063293 | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE Edwards Lifesciences Services GmbH, GB | FJK |
| Jan 30, 2007 | K063290 | GAMBRO QUICKSET BLOODLINES Gambro Renal Products | FJK |
| Aug 16, 2004 | K032975 | JMS BLOOD TUBING SETS Jms North America Corp. | FJK |
| Nov 18, 2002 | K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET Sunder Biomedical Tech. Co., Ltd., TW | FJK |
| Jul 9, 2002 | K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK Bioteque Corp. | FJK |
| Aug 16, 2001 | K012242 | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS Fresenius Medical Care North America | FJK |
| Jul 28, 2000 | K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 Fresenius Medical Care North America | FJK |
| Jun 23, 2000 | K001107 | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) Fresenius Medical Care North America | FJK |
| May 9, 2000 | K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 Fresenius Medical Care North America | FJK |
| Feb 10, 2000 | K992039 | EXEL I.V. BLOOD LINE SET Exelint Intl. Co. | FJK |
| Feb 9, 2000 | K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET Bioteque Corp. | FJK |
| Apr 30, 1999 | K982340 | EXTRACORPOREAL BLOOD CIRCUIT Haidylena Medical Egypt, EG | FJK |
| Dec 24, 1998 | K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR Icu Medical, Inc. | FJK |
| Oct 27, 1997 | K971313 | NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET National Medical Care, Inc. | FJK |
| Jul 29, 1997 | K971687 | HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME National Medical Care, Inc. | FJK |
| Nov 1, 1996 | K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET National Medical Care, Medical Products Div., Inc. | FJK |
| Sep 23, 1996 | K953823 | ARTERIAL VENOUS BLOOD TUBING SET Medisystems Corp. | FJK |
| Apr 30, 1996 | K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS B.Braun Medical, Inc. | FJK |
| Nov 17, 1995 | K950247 | TS 564/PF Bressler, Amery & Ross | FJK |
| Feb 24, 1995 | K921597 | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 Haemotronic, Inc. | FJK |
| Dec 17, 1993 | K934803 | ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS Baxter Healthcare Corp | FJK |
| Sep 21, 1992 | K920797 | HEMODIALYSIS BLOOD TUBING SET National Medical Care, Medical Products Div., Inc. | FJK |
| Nov 1, 1991 | K913526 | SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS Althin Medical AB an Affiliate of Baxter Intl | FJK |
| Aug 7, 1991 | K910558 | TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET Terumo Medical Corp. | FJK |
| Nov 20, 1990 | K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY Gainor Medical Europe, Ltd. | FJK |
| Aug 14, 1990 | K903021 | NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 National Medical Care, Medical Products Div., Inc. | FJK |
| Aug 2, 1990 | K901688 | ARTERIAL/VENOUS BLOODLINES National Medical Care, Medical Products Div., Inc. | FJK |
| Apr 25, 1990 | K896407 | HAEMOTRONIC BLOOD LINE SET Healthcare Suppliers, Inc. | FJK |
| Jun 22, 1989 | K892932 | BIOPRIME TM KIT Hospal | FJK |
| Dec 8, 1988 | K884243 | BLOOD TUBING SET Mediflex Intl. | FJK |
| Sep 14, 1988 | K870722 | LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE National Medical Care, Medical Products Div., Inc. | FJK |
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