Product Code: FJK
FDA class 2
21 CFR 876.5820
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Gastroenterology, Urology
The Blood Tubing Set With and Without Anti-Regurgitation Valve is a set of disposable tubing used to connect the patient's vascular access to the dialyzer during hemodialysis, optionally incorporating a valve to prevent backflow of blood. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FJK, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
510(k)s
74
FEI Numbers
54
Registration Numbers
54
Unique Applicants
50
Years Active
48
Basic Information
- Product Code
- FJK
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✓
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 74 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 ) | Dec 20, 2024 | Substantially Equivalent | Diality, Inc. |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | May 31, 2023 | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC |
| K210782 | Tablo Cartridge | Nov 26, 2021 | Substantially Equivalent | Outset Medical, Inc. |
| K202796 | SANSIN Tubing Sets for Hemodialysis | Sep 06, 2021 | Substantially Equivalent | Jiangxi Sanxin Medtec Co., Ltd. |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Mar 10, 2021 | Substantially Equivalent | Bain Medical Equipment(Guangzhou) Co., Ltd. |
| K171952 | Dimesol Tubing Sets for Hemodialysis | Mar 30, 2018 | Substantially Equivalent | Dimesol, Inc. |
| K161582 | DORA Tubing Sets for Hemodialysis | Jun 16, 2017 | Substantially Equivalent | Bain Medical Equipment (Guangzhou) Co., Ltd |
| K150304 | Oxyless Blood Tubing Set | Feb 24, 2016 | Substantially Equivalent | Oxyless Ltd |
| K140841 | TABLO CARTRIDGE | Sep 11, 2014 | Substantially Equivalent | HOME DIALYSIS PLUS |
| K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | Sep 28, 2012 | Substantially Equivalent | NIPRO MEDICAL CORPORATION |
| K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS | Jun 15, 2012 | Substantially Equivalent | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | Nov 03, 2010 | Substantially Equivalent | GAMBRO RENAL PRODUCTS, INC. |
| K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) | Feb 10, 2009 | Substantially Equivalent | NXSTAGE MEDICAL, INC. |
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) | Jul 18, 2008 | Substantially Equivalent | NXSTAGE MEDICAL, INC. |
| K070414 | GAMBRO CARTRIDGE BLOOD SETS | Oct 12, 2007 | Substantially Equivalent | GAMBRO RENAL PRODUCTS |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | Oct 04, 2007 | Substantially Equivalent | NIPRO MEDICAL CORP. |
| K063293 | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE | Mar 23, 2007 | Substantially Equivalent | EDWARDS LIFESCIENCES SERVICES GMBH |
| K063290 | GAMBRO QUICKSET BLOODLINES | Jan 30, 2007 | Substantially Equivalent | GAMBRO RENAL PRODUCTS |
| K032975 | JMS BLOOD TUBING SETS | Aug 16, 2004 | Substantially Equivalent | JMS NORTH AMERICA CORP. |
| K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET | Nov 18, 2002 | Substantially Equivalent | SUNDER BIOMEDICAL TECH. CO., LTD. |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | Jul 09, 2002 | Unknown | BIOTEQUE CORP. |
| K012242 | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS | Aug 16, 2001 | Substantially Equivalent | FRESENIUS MEDICAL CARE NORTH AMERICA |
| K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 | Jul 28, 2000 | Substantially Equivalent | FRESENIUS MEDICAL CARE NORTH AMERICA |
| K001107 | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) | Jun 23, 2000 | Substantially Equivalent | FRESENIUS MEDICAL CARE NORTH AMERICA |
| K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 | May 09, 2000 | Substantially Equivalent | FRESENIUS MEDICAL CARE NORTH AMERICA |
| K992039 | EXEL I.V. BLOOD LINE SET | Feb 10, 2000 | Substantially Equivalent | EXELINT INTL. CO. |
| K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | Feb 09, 2000 | Substantially Equivalent | BIOTEQUE CORP. |
| K982340 | EXTRACORPOREAL BLOOD CIRCUIT | Apr 30, 1999 | Substantially Equivalent | HAIDYLENA MEDICAL EGYPT |
| K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | Dec 24, 1998 | Substantially Equivalent | ICU MEDICAL, INC. |
| K971313 | NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET | Oct 27, 1997 | Substantially Equivalent | NATIONAL MEDICAL CARE, INC. |
| K971687 | HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME | Jul 29, 1997 | Substantially Equivalent | NATIONAL MEDICAL CARE, INC. |
| K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET | Nov 01, 1996 | Substantially Equivalent | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
| K953823 | ARTERIAL VENOUS BLOOD TUBING SET | Sep 23, 1996 | Substantially Equivalent | MEDISYSTEMS CORP. |
| K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS | Apr 30, 1996 | Substantially Equivalent | B. BRAUN MEDICAL, INC. |
| K950247 | TS 564/PF | Nov 17, 1995 | Substantially Equivalent | BRESSLER, AMERY & ROSS |
| K921597 | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 | Feb 24, 1995 | Substantially Equivalent | HAEMOTRONIC, INC. |
| K934803 | ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS | Dec 17, 1993 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K920797 | HEMODIALYSIS BLOOD TUBING SET | Sep 21, 1992 | Substantially Equivalent | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
| K913526 | SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS | Nov 01, 1991 | Substantially Equivalent | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
| K910558 | TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET | Aug 07, 1991 | Substantially Equivalent | TERUMO MEDICAL CORP. |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Nov 20, 1990 | Substantially Equivalent | GAINOR MEDICAL EUROPE, LTD. |
| K903021 | NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 | Aug 14, 1990 | Substantially Equivalent | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
| K901688 | ARTERIAL/VENOUS BLOODLINES | Aug 02, 1990 | Substantially Equivalent | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
| K896407 | HAEMOTRONIC BLOOD LINE SET | Apr 25, 1990 | Substantially Equivalent | HEALTHCARE SUPPLIERS, INC. |
| K892932 | BIOPRIME TM KIT | Jun 22, 1989 | Substantially Equivalent | HOSPAL |
| K884243 | BLOOD TUBING SET | Dec 08, 1988 | Substantially Equivalent | MEDIFLEX INTL. |
| K870722 | LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE | Sep 14, 1988 | Substantially Equivalent | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
| K873516 | KAWASUMI BLOOD TUBING LINE | Oct 05, 1987 | Substantially Equivalent | KAWASUMI LABORATORIES CO., LTD. |
| K873455 | S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS | Sep 14, 1987 | Substantially Equivalent | DRAVON MEDICAL, INC. |
| K864784 | SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS | Jan 20, 1987 | Substantially Equivalent | CD MEDICAL, INC. |
| K860740 | ERIKA ARTERIAL LINE 03-9625-9 | Mar 14, 1986 | Substantially Equivalent | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
| K853851 | FRESENIUS DISPOSABLE BLOOD LINES | Nov 12, 1985 | Substantially Equivalent | SERATRONICS, INC. |
| K854271 | ASA BLOOD TUBING LINES | Nov 05, 1985 | Substantially Equivalent | ORGANON TEKNIKA CORP. |
| K853962 | ERIKA ARTERIAL LINE 03-9837-0 | Oct 18, 1985 | Substantially Equivalent | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
| K852605 | BLOOD TUBING SET | Jul 29, 1985 | Substantially Equivalent | MEDFLEX INTERNATIONAL, INC. |
| K852309 | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 | Jul 26, 1985 | Substantially Equivalent | ERIKA, INC. |
| K851236 | HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES | Jul 26, 1985 | Substantially Equivalent | INFARKEM CORP. |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | Oct 14, 1983 | Substantially Equivalent | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
| K831747 | PLASMA THERAPY TUBESET-E100 SERIES | Jun 30, 1983 | Substantially Equivalent | PARKER HANNIFIN CORP. |
| K830677 | BLOOD LINE SETS FOR HEMOFILTRATION | Apr 12, 1983 | Substantially Equivalent | GAMBRO, INC. |
| K821138 | TS-180 SERIES TUBING SET | May 10, 1982 | Substantially Equivalent | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
| K820169 | MALE LUER CONNECTOR & HINGED CAP | Feb 05, 1982 | Substantially Equivalent | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
| K812685 | ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE | Sep 29, 1981 | Substantially Equivalent | ERICKA |
| K811839 | MEDISYSTEM NEGATIVE PRESSURE | Sep 08, 1981 | Substantially Equivalent | MEDISYSTEMS CORP. |
| K810824 | ERIKA HEPARIN INFUSION ADAPTOR | Apr 17, 1981 | Substantially Equivalent | ERIKA, INC. |
| K810823 | ERIKA EXTENSION SETS | Apr 17, 1981 | Substantially Equivalent | ERIKA, INC. |
| K802874 | ARTERIOVENOUS BLOOD TUBING SETS | Nov 25, 1980 | Substantially Equivalent | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
| K801211 | COBE HEMOFLO BLOOD TUBING SETS | Jul 14, 1980 | Substantially Equivalent | COBE LABORATORIES, INC. |
| K801016 | GAMBRO G SERIES BLOOD LINE SETS FOR HEM. | May 30, 1980 | Substantially Equivalent | GAMBRO, INC. |
| K792054 | ERIKA NEGATIVE PRESSURE VENOUS BL SETS | Dec 06, 1979 | Substantially Equivalent | ERIKA, INC. |
| K792053 | ERIKA NEGATIVE PRESSURE ARTERILA BLOOD | Dec 06, 1979 | Substantially Equivalent | ERIKA, INC. |
| K780681 | ARTERIOVENOUS BLOOD TUBING SETS | Jun 14, 1978 | Substantially Equivalent | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
| K771693 | CLIRANS BLOOD LINES SET | Sep 20, 1977 | Substantially Equivalent | TERUMO AMERICA, INC. |
| K761326 | ARTERIOVENOUS BLOOD TUBING SETS | Jan 10, 1977 | Substantially Equivalent | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
FEI Numbers
This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.