FJK · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Gastroenterology, Urology · 21 CFR 876.5820 · Class 2
Overview
| Product Code | FJK |
|---|---|
| Device Name | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Regulation | 21 CFR 876.5820 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Life-Sustaining | Yes |
Identification
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
Classification Rationale
(1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (76)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | Jan 16, 2026 | SESE |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | Oct 2, 2025 | SESE |
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 ) | Diality, Inc. | Dec 20, 2024 | SESE |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | May 31, 2023 | SESE |
| K210782 | Tablo Cartridge | Outset Medical, Inc. | Nov 26, 2021 | SESE |
| K202796 | SANSIN Tubing Sets for Hemodialysis | Jiangxi Sanxin Medtec Co., Ltd. | Sep 6, 2021 | SESE |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | Mar 10, 2021 | SESE |
| K171952 | Dimesol Tubing Sets for Hemodialysis | Dimesol, Inc. | Mar 30, 2018 | SESE |
| K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | Jun 16, 2017 | SESE |
| K150304 | Oxyless Blood Tubing Set | Oxyless, Ltd. | Feb 24, 2016 | SESE |
| K140841 | TABLO CARTRIDGE | Home Dialysis Plus | Sep 11, 2014 | SESE |
| K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | Nipro Medical Corporation | Sep 28, 2012 | SESE |
| K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS | Fresenius Medical Care North America, Design Cente | Jun 15, 2012 | SESE |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | Gambro Renal Products, Inc. | Nov 3, 2010 | SESE |
| K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | Feb 10, 2009 | SESE |
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | Jul 18, 2008 | SESE |
| K070414 | GAMBRO CARTRIDGE BLOOD SETS | Gambro Renal Products | Oct 12, 2007 | SESE |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | Nipro Medical Corp. | Oct 4, 2007 | SESE |
| K063293 | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE | Edwards Lifesciences Services GmbH | Mar 23, 2007 | SESE |
| K063290 | GAMBRO QUICKSET BLOODLINES | Gambro Renal Products | Jan 30, 2007 | SESE |
| K032975 | JMS BLOOD TUBING SETS | Jms North America Corp. | Aug 16, 2004 | SESE |
| K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET | Sunder Biomedical Tech. Co., Ltd. | Nov 18, 2002 | SESE |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | Bioteque Corp. | Jul 9, 2002 | SESK |
| K012242 | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS | Fresenius Medical Care North America | Aug 16, 2001 | SESE |
| K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 | Fresenius Medical Care North America | Jul 28, 2000 | SESE |
| K001107 | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) | Fresenius Medical Care North America | Jun 23, 2000 | SESE |
| K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 | Fresenius Medical Care North America | May 9, 2000 | SESE |
| K992039 | EXEL I.V. BLOOD LINE SET | Exelint Intl. Co. | Feb 10, 2000 | SESE |
| K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | Bioteque Corp. | Feb 9, 2000 | SESE |
| K982340 | EXTRACORPOREAL BLOOD CIRCUIT | Haidylena Medical Egypt | Apr 30, 1999 | SESE |
| K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | Icu Medical, Inc. | Dec 24, 1998 | SESE |
| K971313 | NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET | National Medical Care, Inc. | Oct 27, 1997 | SESE |
| K971687 | HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME | National Medical Care, Inc. | Jul 29, 1997 | SESE |
| K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET | National Medical Care, Medical Products Div., Inc. | Nov 1, 1996 | SESE |
| K953823 | ARTERIAL VENOUS BLOOD TUBING SET | Medisystems Corp. | Sep 23, 1996 | SESE |
| K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS | B.Braun Medical, Inc. | Apr 30, 1996 | SESE |
| K950247 | TS 564/PF | Bressler, Amery & Ross | Nov 17, 1995 | SESE |
| K921597 | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 | Haemotronic, Inc. | Feb 24, 1995 | SESE |
| K934803 | ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS | Baxter Healthcare Corp | Dec 17, 1993 | SESE |
| K920797 | HEMODIALYSIS BLOOD TUBING SET | National Medical Care, Medical Products Div., Inc. | Sep 21, 1992 | SESE |
| K913526 | SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS | Althin Medical AB an Affiliate of Baxter Intl | Nov 1, 1991 | SESE |
| K910558 | TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET | Terumo Medical Corp. | Aug 7, 1991 | SESE |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Gainor Medical Europe, Ltd. | Nov 20, 1990 | SESE |
| K903021 | NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 | National Medical Care, Medical Products Div., Inc. | Aug 14, 1990 | SESE |
| K901688 | ARTERIAL/VENOUS BLOODLINES | National Medical Care, Medical Products Div., Inc. | Aug 2, 1990 | SESE |
| K896407 | HAEMOTRONIC BLOOD LINE SET | Healthcare Suppliers, Inc. | Apr 25, 1990 | SESE |
| K892932 | BIOPRIME TM KIT | Hospal | Jun 22, 1989 | SESE |
| K884243 | BLOOD TUBING SET | Mediflex Intl. | Dec 8, 1988 | SESE |
| K870722 | LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE | National Medical Care, Medical Products Div., Inc. | Sep 14, 1988 | SESE |
| K873516 | KAWASUMI BLOOD TUBING LINE | Kawasumi Laboratories Co., Ltd. | Oct 5, 1987 | SESE |
| K873455 | S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS | Dravon Medical, Inc. | Sep 14, 1987 | SESE |
| K864784 | SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS | Cd Medical, Inc. | Jan 20, 1987 | SESE |
| K860740 | ERIKA ARTERIAL LINE 03-9625-9 | National Medical Care, Medical Products Div., Inc. | Mar 14, 1986 | SESE |
| K853851 | FRESENIUS DISPOSABLE BLOOD LINES | Seratronics, Inc. | Nov 12, 1985 | SESE |
| K854271 | ASA BLOOD TUBING LINES | Organon Teknika Corp. | Nov 5, 1985 | SESE |
| K853962 | ERIKA ARTERIAL LINE 03-9837-0 | National Medical Care, Medical Products Div., Inc. | Oct 18, 1985 | SESE |
| K852605 | BLOOD TUBING SET | Medflex International, Inc. | Jul 29, 1985 | SESE |
| K852309 | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 | Erika, Inc. | Jul 26, 1985 | SESE |
| K851236 | HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES | Infarkem Corp. | Jul 26, 1985 | SESE |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | Extracorporeal Medical Specialities, Inc. | Oct 14, 1983 | SESE |
| K831747 | PLASMA THERAPY TUBESET-E100 SERIES | Parker Hannifin Corp. | Jun 30, 1983 | SESE |
| K830677 | BLOOD LINE SETS FOR HEMOFILTRATION | Gambro, Inc. | Apr 12, 1983 | SESE |
| K821138 | TS-180 SERIES TUBING SET | Extracorporeal Medical Specialities, Inc. | May 10, 1982 | SESE |
| K820169 | MALE LUER CONNECTOR & HINGED CAP | Extracorporeal Medical Specialities, Inc. | Feb 5, 1982 | SESE |
| K812685 | ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE | Ericka | Sep 29, 1981 | SESE |
| K811839 | MEDISYSTEM NEGATIVE PRESSURE | Medisystems Corp. | Sep 8, 1981 | SESE |
| K810824 | ERIKA HEPARIN INFUSION ADAPTOR | Erika, Inc. | Apr 17, 1981 | SESE |
| K810823 | ERIKA EXTENSION SETS | Erika, Inc. | Apr 17, 1981 | SESE |
| K802874 | ARTERIOVENOUS BLOOD TUBING SETS | Extracorporeal Medical Specialities, Inc. | Nov 25, 1980 | SESE |
| K801211 | COBE HEMOFLO BLOOD TUBING SETS | Cobe Laboratories, Inc. | Jul 14, 1980 | SESE |
| K801016 | GAMBRO G SERIES BLOOD LINE SETS FOR HEM. | Gambro, Inc. | May 30, 1980 | SESE |
| K792054 | ERIKA NEGATIVE PRESSURE VENOUS BL SETS | Erika, Inc. | Dec 6, 1979 | SESE |
| K792053 | ERIKA NEGATIVE PRESSURE ARTERILA BLOOD | Erika, Inc. | Dec 6, 1979 | SESE |
| K780681 | ARTERIOVENOUS BLOOD TUBING SETS | Extracorporeal Medical Specialities, Inc. | Jun 14, 1978 | SESE |
| K771693 | CLIRANS BLOOD LINES SET | Terumo America, Inc. | Sep 20, 1977 | SESE |
| K761326 | ARTERIOVENOUS BLOOD TUBING SETS | Extracorporeal Medical Specialities, Inc. | Jan 10, 1977 | SESE |
Top Applicants
- National Medical Care, Medical Products Div., Inc. — 7 clearances
- Extracorporeal Medical Specialities, Inc. — 6 clearances
- Erika, Inc. — 5 clearances
- Fresenius Medical Care North America — 4 clearances
- Nxstage Medical, Inc. — 2 clearances
