Product code FJK
- Device name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2026-05-15 |
| K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | 2026-01-16 |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2025-10-02 |
| K243607 | Moda-flx Hemodialysis System™ Cartridge (102121-001 ) | Diality, Inc. | 2024-12-20 |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-31 |
| K210782 | Tablo Cartridge | Outset Medical, Inc. | 2021-11-26 |
| K202796 | SANSIN Tubing Sets for Hemodialysis | Jiangxi Sanxin Medtec Co., Ltd. | 2021-09-06 |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-03-10 |
| K171952 | Dimesol Tubing Sets for Hemodialysis | Dimesol, Inc. | 2018-03-30 |
| K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-06-16 |
| K150304 | Oxyless Blood Tubing Set | Oxyless, Ltd. | 2016-02-24 |
| K140841 | TABLO CARTRIDGE | Home Dialysis Plus | 2014-09-11 |
| K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | Nipro Medical Corporation | 2012-09-28 |
| K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS | Fresenius Medical Care North America, Design Cente | 2012-06-15 |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | Gambro Renal Products, Inc. | 2010-11-03 |
| K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | 2009-02-10 |
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | 2008-07-18 |
| K070414 | GAMBRO CARTRIDGE BLOOD SETS | Gambro Renal Products | 2007-10-12 |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | Nipro Medical Corp. | 2007-10-04 |
| K063293 | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE | Edwards Lifesciences Services GmbH | 2007-03-23 |
| K063290 | GAMBRO QUICKSET BLOODLINES | Gambro Renal Products | 2007-01-30 |
| K032975 | JMS BLOOD TUBING SETS | Jms North America Corp. | 2004-08-16 |
| K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET | Sunder Biomedical Tech. Co., Ltd. | 2002-11-18 |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | Bioteque Corp. | 2002-07-09 |
| K012242 | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS | Fresenius Medical Care North America | 2001-08-16 |
| K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 | Fresenius Medical Care North America | 2000-07-28 |
| K001107 | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) | Fresenius Medical Care North America | 2000-06-23 |
| K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 | Fresenius Medical Care North America | 2000-05-09 |
| K992039 | EXEL I.V. BLOOD LINE SET | Exelint Intl. Co. | 2000-02-10 |
| K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | Bioteque Corp. | 2000-02-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00383790011907 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2025-06-01 |
| 00383790011891 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2025-06-01 |
| 00383790011884 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2025-06-01 |
| 00383790011877 | SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2025-06-01 |
| 00704411011852 | BD Blood Pump transfusion set | AMSINO INTERNATIONAL, INC. | 2020-06-12 |
| 10704411004875 | "AMSafe® 105"" (267cm) Y-Type Blood Set" | AMSINO INTERNATIONAL, INC. | 2016-09-23 |
| 10704411004868 | "AMSafe® 102"" (259cm) Y-Type Blood Set" | AMSINO INTERNATIONAL, INC. | 2016-09-23 |
| 10704411004882 | "AMSafe® 94"" (239cm) Y-Type Blood Set" | AMSINO INTERNATIONAL, INC. | 2016-09-23 |
| M535SL2000M2095W0 | Streamline Airless System Set with Locksite Needleless Access Sites | NXSTAGE MEDICAL, INC. | 2016-09-12 |
| M535SL2050M20550 | Streamline Airless System Set with Locksite Needleless Access Sites | NXSTAGE MEDICAL, INC. | 2015-10-30 |
| 10840861100825 | Fresenius HemaClip | Fresenius Medical Care Holdings, Inc. | 2015-09-30 |
| 00383790004060 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004176 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004152 | SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004121 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004114 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004091 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004077 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004053 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004046 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004039 | NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| M535B36605M67920 | Medisystems Hemodialysis Blood Tubing Sets | MEDISYSTEMS CORPORATION | 2015-09-01 |
| M535SL2011M20980 | Streamline Airless System Set with Locksite Needleless Access Sites and SecureCl | MEDISYSTEMS CORPORATION | 2015-09-01 |
| M535SL2010M20960 | Streamline Airless System Set with Locksite Needleless Access Sites | MEDISYSTEMS CORPORATION | 2015-09-01 |
| M535SL2000M2095L0 | Streamline Airless System Set with Locksite Needleless Access Sites and SecureCl | MEDISYSTEMS CORPORATION | 2015-09-01 |
| M535B36604M67920 | Medisystems Hemodialysis Blood Tubing Sets | MEDISYSTEMS CORPORATION | 2015-09-01 |
| M535B34630M47050 | Medisystems Hemodialysis Blood Tubing Sets | MEDISYSTEMS CORPORATION | 2015-09-01 |
| M535B33632M37050 | Medisystems Hemodialysis Blood Tubing Sets | MEDISYSTEMS CORPORATION | 2015-09-01 |
| M535SL2000M2095D0 | Streamline Airless System Set with Locksite Needleless Access Sites | MEDISYSTEMS CORPORATION | 2015-09-01 |
| M535SL2000M20950 | Streamline Airless System Set with Locksite Needleless Access Sites | MEDISYSTEMS CORPORATION | 2015-09-01 |