Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

FDA product code FJK · 76 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5820
Review panel: GU
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1977-01-10 – 2026-05-15

FJK 2026-05-15

NovaLine Tubing Set for Hemodialysis (BL 124)

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K number K252423

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FJK 2026-01-16

VITAL Tubing Sets for Hemodialysis

Applicant Vital Healthcare Sdn. Bhd.

K number K251341

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FJK 2025-10-02

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

Applicant Ningbo Tianyi Medical Appliance Co., Ltd.

K number K251442

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FJK 2024-12-20

Moda-flx Hemodialysis System™ Cartridge (102121-001 )

Applicant Diality, Inc.

K number K243607

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FJK 2023-05-31

CombiSet Hemodialysis Blood Tubing Set

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K213992

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FJK 2021-11-26

Tablo Cartridge

Applicant Outset Medical, Inc.

K number K210782

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FJK 2021-09-06

SANSIN Tubing Sets for Hemodialysis

Applicant Jiangxi Sanxin Medtec Co., Ltd.

K number K202796

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FJK 2021-03-10

NovaLine Tubing Sets for Hemodialysis

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K number K201866

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FJK 2018-03-30

Dimesol Tubing Sets for Hemodialysis

Applicant Dimesol, Inc.

K number K171952

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FJK 2017-06-16

DORA Tubing Sets for Hemodialysis

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K number K161582

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FJK 2016-02-24

Oxyless Blood Tubing Set

Applicant Oxyless, Ltd.

K number K150304

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FJK 2012-09-28

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

Applicant Nipro Medical Corporation

K number K112628

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FJK 2012-06-15

BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS

Applicant Fresenius Medical Care North America, Design Cente

K number K120823

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FJK 2010-11-03

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

Applicant Gambro Renal Products, Inc.

K number K100364

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FJK 2009-02-10

BLOOD TUBING SETS (STERILE FLUID PATH)

Applicant Nxstage Medical, Inc.

K number K090255

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FJK 2008-07-18

BLOOD TUBING SETS (STERILE FLUID PATH)

Applicant Nxstage Medical, Inc.

K number K080807

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FJK 2007-10-12

GAMBRO CARTRIDGE BLOOD SETS

Applicant Gambro Renal Products

K number K070414

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FJK 2007-10-04

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693

Applicant Nipro Medical Corp.

K number K072024

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FJK 2007-03-23

EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE

Applicant Edwards Lifesciences Services GmbH

K number K063293

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FJK 2007-01-30

GAMBRO QUICKSET BLOODLINES

Applicant Gambro Renal Products

K number K063290

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FJK 2004-08-16

JMS BLOOD TUBING SETS

Applicant Jms North America Corp.

K number K032975

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FJK 2002-11-18

RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET

Applicant Sunder Biomedical Tech. Co., Ltd.

K number K014140

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FJK 2002-07-09

BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK

Applicant Bioteque Corp.

K number K013634

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FJK 2001-08-16

FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS

Applicant Fresenius Medical Care North America

K number K012242

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FJK 2000-07-28

HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0

Applicant Fresenius Medical Care North America

K number K001873

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FJK 2000-06-23

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

Applicant Fresenius Medical Care North America

K number K001107

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FJK 2000-05-09

FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290

Applicant Fresenius Medical Care North America

K number K000451

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FJK 2000-02-10

EXEL I.V. BLOOD LINE SET

Applicant Exelint Intl. Co.

K number K992039

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FJK 2000-02-09

BIOTEQUE HEMODIALYSIS BLOOD TUBING SET

Applicant Bioteque Corp.

K number K992930

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FJK 1999-04-30

EXTRACORPOREAL BLOOD CIRCUIT

Applicant Haidylena Medical Egypt

K number K982340

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FJK 1998-12-24

BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR

Applicant Icu Medical, Inc.

K number K983559

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FJK 1997-10-27

NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET

Applicant National Medical Care, Inc.

K number K971313

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FJK 1997-07-29

HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME

Applicant National Medical Care, Inc.

K number K971687

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FJK 1996-11-01

COMBILINES HEMODIALYSIS BLOOD TUBING SET

Applicant National Medical Care, Medical Products Div., Inc.

K number K962081

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FJK 1996-09-23

ARTERIAL VENOUS BLOOD TUBING SET

Applicant Medisystems Corp.

K number K953823

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FJK 1996-04-30

BRAUN HEMODIALYSIS BLOOD CIRCUITS

Applicant B.Braun Medical, Inc.

K number K952631

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FJK 1995-11-17

TS 564/PF

Applicant Bressler, Amery & Ross

K number K950247

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FJK 1995-02-24

CAVH/CVVH/CAVHD SET MODEL #HT-HF/505

Applicant Haemotronic, Inc.

K number K921597

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FJK 1993-12-17

ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS

Applicant Baxter Healthcare Corp

K number K934803

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FJK 1992-09-21

HEMODIALYSIS BLOOD TUBING SET

Applicant National Medical Care, Medical Products Div., Inc.

K number K920797

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FJK 1991-11-01

SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K913526

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FJK 1991-08-07

TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET

Applicant Terumo Medical Corp.

K number K910558

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FJK 1990-11-20

HEMODIALYSIS SYSTEM AND ACCESSORY

Applicant Gainor Medical Europe, Ltd.

K number K902426

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FJK 1990-08-14

NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630

Applicant National Medical Care, Medical Products Div., Inc.

K number K903021

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FJK 1990-08-02

ARTERIAL/VENOUS BLOODLINES

Applicant National Medical Care, Medical Products Div., Inc.

K number K901688

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FJK 1990-04-25

HAEMOTRONIC BLOOD LINE SET

Applicant Healthcare Suppliers, Inc.

K number K896407

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FJK 1989-06-22

BIOPRIME TM KIT

Applicant Hospal

K number K892932

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FJK 1988-12-08

BLOOD TUBING SET

Applicant Mediflex Intl.

K number K884243

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FJK 1988-09-14

LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE

Applicant National Medical Care, Medical Products Div., Inc.

K number K870722

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FJK 1987-10-05

KAWASUMI BLOOD TUBING LINE

Applicant Kawasumi Laboratories Co., Ltd.

K number K873516

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FJK 1987-09-14

S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS

Applicant Dravon Medical, Inc.

K number K873455

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FJK 1987-01-20

SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS

Applicant Cd Medical, Inc.

K number K864784

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FJK 1986-03-14

ERIKA ARTERIAL LINE 03-9625-9

Applicant National Medical Care, Medical Products Div., Inc.

K number K860740

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FJK 1985-11-12

FRESENIUS DISPOSABLE BLOOD LINES

Applicant Seratronics, Inc.

K number K853851

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FJK 1985-11-05

ASA BLOOD TUBING LINES

Applicant Organon Teknika Corp.

K number K854271

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FJK 1985-10-18

ERIKA ARTERIAL LINE 03-9837-0

Applicant National Medical Care, Medical Products Div., Inc.

K number K853962

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FJK 1985-07-29

BLOOD TUBING SET

Applicant Medflex International, Inc.

K number K852605

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FJK 1985-07-26

ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1

Applicant Erika, Inc.

K number K852309

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FJK 1985-07-26

HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES

Applicant Infarkem Corp.

K number K851236

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FJK 1983-10-14

THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101

Applicant Extracorporeal Medical Specialities, Inc.

K number K831424

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FJK 1983-06-30

PLASMA THERAPY TUBESET-E100 SERIES

Applicant Parker Hannifin Corp.

K number K831747

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FJK 1983-04-12

BLOOD LINE SETS FOR HEMOFILTRATION

Applicant Gambro, Inc.

K number K830677

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FJK 1982-05-10

TS-180 SERIES TUBING SET

Applicant Extracorporeal Medical Specialities, Inc.

K number K821138

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FJK 1982-02-05

MALE LUER CONNECTOR & HINGED CAP

Applicant Extracorporeal Medical Specialities, Inc.

K number K820169

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FJK 1981-09-29

ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE

Applicant Ericka

K number K812685

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FJK 1981-09-08

MEDISYSTEM NEGATIVE PRESSURE

Applicant Medisystems Corp.

K number K811839

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FJK 1981-04-17

ERIKA HEPARIN INFUSION ADAPTOR

Applicant Erika, Inc.

K number K810824

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FJK 1981-04-17

ERIKA EXTENSION SETS

Applicant Erika, Inc.

K number K810823

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FJK 1980-11-25

ARTERIOVENOUS BLOOD TUBING SETS

Applicant Extracorporeal Medical Specialities, Inc.

K number K802874

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FJK 1980-07-14

COBE HEMOFLO BLOOD TUBING SETS

Applicant Cobe Laboratories, Inc.

K number K801211

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FJK 1980-05-30

GAMBRO G SERIES BLOOD LINE SETS FOR HEM.

Applicant Gambro, Inc.

K number K801016

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FJK 1979-12-06

ERIKA NEGATIVE PRESSURE VENOUS BL SETS

Applicant Erika, Inc.

K number K792054

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FJK 1979-12-06

ERIKA NEGATIVE PRESSURE ARTERILA BLOOD

Applicant Erika, Inc.

K number K792053

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FJK 1978-06-14

ARTERIOVENOUS BLOOD TUBING SETS

Applicant Extracorporeal Medical Specialities, Inc.

K number K780681

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FJK 1977-09-20

CLIRANS BLOOD LINES SET

Applicant Terumo America, Inc.

K number K771693

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FJK 1977-01-10

ARTERIOVENOUS BLOOD TUBING SETS

Applicant Extracorporeal Medical Specialities, Inc.

K number K761326

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