FDA 510(k) Applications for Medical Device Product Code "FJK"
(Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K952631 | B. BRAUN MEDICAL, INC. | BRAUN HEMODIALYSIS BLOOD CIRCUITS | 04/30/1996 |
| K161582 | Bain Medical Equipment (Guangzhou) Co., Ltd | DORA Tubing Sets for Hemodialysis | 06/16/2017 |
| K201866 | Bain Medical Equipment(Guangzhou) Co., Ltd. | NovaLine Tubing Sets for Hemodialysis | 03/10/2021 |
| K013634 | BIOTEQUE CORP. | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | 07/09/2002 |
| K992930 | BIOTEQUE CORP. | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | 02/09/2000 |
| K171952 | Dimesol, Inc. | Dimesol Tubing Sets for Hemodialysis | 03/30/2018 |
| K063293 | EDWARDS LIFESCIENCES SERVICES GMBH | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE | 03/23/2007 |
| K992039 | EXELINT INTL. CO. | EXEL I.V. BLOOD LINE SET | 02/10/2000 |
| K012242 | FRESENIUS MEDICAL CARE NORTH AMERICA | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS | 08/16/2001 |
| K001107 | FRESENIUS MEDICAL CARE NORTH AMERICA | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) | 06/23/2000 |
| K000451 | FRESENIUS MEDICAL CARE NORTH AMERICA | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 | 05/09/2000 |
| K001873 | FRESENIUS MEDICAL CARE NORTH AMERICA | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 | 07/28/2000 |
| K120823 | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS | 06/15/2012 |
| K213992 | Fresenius Medical Care Renal Therapies Group, LLC | CombiSet Hemodialysis Blood Tubing Set | 05/31/2023 |
| K070414 | GAMBRO RENAL PRODUCTS | GAMBRO CARTRIDGE BLOOD SETS | 10/12/2007 |
| K063290 | GAMBRO RENAL PRODUCTS | GAMBRO QUICKSET BLOODLINES | 01/30/2007 |
| K100364 | GAMBRO RENAL PRODUCTS, INC. | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | 11/03/2010 |
| K982340 | HAIDYLENA MEDICAL EGYPT | EXTRACORPOREAL BLOOD CIRCUIT | 04/30/1999 |
| K140841 | HOME DIALYSIS PLUS | TABLO CARTRIDGE | 09/11/2014 |
| K983559 | ICU MEDICAL, INC. | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | 12/24/1998 |
| K202796 | Jiangxi Sanxin Medtec Co., Ltd. | SANSIN Tubing Sets for Hemodialysis | 09/06/2021 |
| K032975 | JMS NORTH AMERICA CORP. | JMS BLOOD TUBING SETS | 08/16/2004 |
| K953823 | MEDISYSTEMS CORP. | ARTERIAL VENOUS BLOOD TUBING SET | 09/23/1996 |
| K971687 | NATIONAL MEDICAL CARE, INC. | HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME | 07/29/1997 |
| K971313 | NATIONAL MEDICAL CARE, INC. | NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET | 10/27/1997 |
| K962081 | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. | COMBILINES HEMODIALYSIS BLOOD TUBING SET | 11/01/1996 |
| K072024 | NIPRO MEDICAL CORP. | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | 10/04/2007 |
| K112628 | NIPRO MEDICAL CORPORATION | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | 09/28/2012 |
| K080807 | NXSTAGE MEDICAL, INC. | BLOOD TUBING SETS (STERILE FLUID PATH) | 07/18/2008 |
| K090255 | NXSTAGE MEDICAL, INC. | BLOOD TUBING SETS (STERILE FLUID PATH) | 02/10/2009 |
| K210782 | Outset Medical, Inc. | Tablo Cartridge | 11/26/2021 |
| K150304 | Oxyless Ltd | Oxyless Blood Tubing Set | 02/24/2016 |
| K014140 | SUNDER BIOMEDICAL TECH. CO., LTD. | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET | 11/18/2002 |
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