FDA Product Code
FDA Product Code FJK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 77 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2026-05-15 | Traditional | PDF ↗ |
| K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | 2026-01-16 | Traditional | PDF ↗ |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2025-10-02 | Traditional | PDF ↗ |
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 ) | Diality, Inc. | 2024-12-20 | Special | PDF ↗ |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-31 | Traditional | PDF ↗ |
| K210782 | Tablo Cartridge | Outset Medical, Inc. | 2021-11-26 | Traditional | PDF ↗ |
| K202796 | SANSIN Tubing Sets for Hemodialysis | Jiangxi Sanxin Medtec Co., Ltd. | 2021-09-06 | Traditional | PDF ↗ |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-03-10 | Traditional | PDF ↗ |
| K171952 | Dimesol Tubing Sets for Hemodialysis | Dimesol, Inc. | 2018-03-30 | Traditional | PDF ↗ |
| K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-06-16 | Traditional | PDF ↗ |
| K150304 | Oxyless Blood Tubing Set | Oxyless, Ltd. | 2016-02-24 | Abbreviated | PDF ↗ |
| K140841 | TABLO CARTRIDGE | Home Dialysis Plus | 2014-09-11 | Traditional | PDF ↗ |
| K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | Nipro Medical Corporation | 2012-09-28 | Special | PDF ↗ |
| K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS | Fresenius Medical Care North America, Design Cente | 2012-06-15 | Traditional | PDF ↗ |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | Gambro Renal Products, Inc. | 2010-11-03 | Traditional | PDF ↗ |
| K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | 2009-02-10 | Special | PDF ↗ |
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | 2008-07-18 | Special | PDF ↗ |
| K070414 | GAMBRO CARTRIDGE BLOOD SETS | Gambro Renal Products | 2007-10-12 | Traditional | PDF ↗ |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | Nipro Medical Corp. | 2007-10-04 | Special | PDF ↗ |
| K063293 | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE | Edwards Lifesciences Services GmbH | 2007-03-23 | Traditional | PDF ↗ |
| K063290 | GAMBRO QUICKSET BLOODLINES | Gambro Renal Products | 2007-01-30 | Traditional | PDF ↗ |
| K032975 | JMS BLOOD TUBING SETS | Jms North America Corp. | 2004-08-16 | Traditional | PDF ↗ |
| K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET | Sunder Biomedical Tech. Co., Ltd. | 2002-11-18 | Traditional | PDF ↗ |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | Bioteque Corp. | 2002-07-09 | Traditional | PDF ↗ |
| K012242 | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS | Fresenius Medical Care North America | 2001-08-16 | Special | PDF ↗ |
| K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 | Fresenius Medical Care North America | 2000-07-28 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 | Fresenius Medical Care North America | 2000-05-09 | Traditional | PDF ↗ |
| K992039 | EXEL I.V. BLOOD LINE SET | Exelint Intl. Co. | 2000-02-10 | Traditional | PDF ↗ |
| K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | Bioteque Corp. | 2000-02-09 | Traditional | PDF ↗ |
| K982340 | EXTRACORPOREAL BLOOD CIRCUIT | Haidylena Medical Egypt | 1999-04-30 | Traditional | PDF ↗ |
| K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | Icu Medical, Inc. | 1998-12-24 | Traditional | PDF ↗ |
| K971313 | NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET | National Medical Care, Inc. | 1997-10-27 | Traditional | PDF ↗ |
| K971687 | HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME | National Medical Care, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET | National Medical Care, Medical Products Div., Inc. | 1996-11-01 | Traditional | PDF ↗ |
| K953823 | ARTERIAL VENOUS BLOOD TUBING SET | Medisystems Corp. | 1996-09-23 | Traditional | PDF ↗ |
| K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS | B.Braun Medical, Inc. | 1996-04-30 | Traditional | PDF ↗ |
| K950247 | TS 564/PF | Bressler, Amery & Ross | 1995-11-17 | Traditional | PDF ↗ |
| K921597 | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 | Haemotronic, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K934803 | ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS | Baxter Healthcare Corp | 1993-12-17 | Traditional | PDF ↗ |
| K920797 | HEMODIALYSIS BLOOD TUBING SET | National Medical Care, Medical Products Div., Inc. | 1992-09-21 | Traditional | PDF ↗ |
| K913526 | SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS | Althin Medical AB an Affiliate of Baxter Intl | 1991-11-01 | Traditional | PDF ↗ |
| K910558 | TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET | Terumo Medical Corp. | 1991-08-07 | Traditional | PDF ↗ |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Gainor Medical Europe, Ltd. | 1990-11-20 | Traditional | PDF ↗ |
| K903021 | NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 | National Medical Care, Medical Products Div., Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K901688 | ARTERIAL/VENOUS BLOODLINES | National Medical Care, Medical Products Div., Inc. | 1990-08-02 | Traditional | PDF ↗ |
| K896407 | HAEMOTRONIC BLOOD LINE SET | Healthcare Suppliers, Inc. | 1990-04-25 | Traditional | PDF ↗ |
| K892932 | BIOPRIME TM KIT | Hospal | 1989-06-22 | Traditional | PDF ↗ |
| K884243 | BLOOD TUBING SET | Mediflex Intl. | 1988-12-08 | Traditional | PDF ↗ |
| K870722 | LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE | National Medical Care, Medical Products Div., Inc. | 1988-09-14 | Traditional | PDF ↗ |
| K873516 | KAWASUMI BLOOD TUBING LINE | Kawasumi Laboratories Co., Ltd. | 1987-10-05 | Traditional | PDF ↗ |
| K873455 | S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS | Dravon Medical, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K864784 | SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS | Cd Medical, Inc. | 1987-01-20 | Traditional | PDF ↗ |
| K860740 | ERIKA ARTERIAL LINE 03-9625-9 | National Medical Care, Medical Products Div., Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K853851 | FRESENIUS DISPOSABLE BLOOD LINES | Seratronics, Inc. | 1985-11-12 | Traditional | PDF ↗ |
| K854271 | ASA BLOOD TUBING LINES | Organon Teknika Corp. | 1985-11-05 | Traditional | PDF ↗ |
| K853962 | ERIKA ARTERIAL LINE 03-9837-0 | National Medical Care, Medical Products Div., Inc. | 1985-10-18 | Traditional | PDF ↗ |
| K852605 | BLOOD TUBING SET | Medflex International, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K852309 | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 | Erika, Inc. | 1985-07-26 | Traditional | PDF ↗ |
| K851236 | HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES | Infarkem Corp. | 1985-07-26 | Traditional | PDF ↗ |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | Extracorporeal Medical Specialities, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K831747 | PLASMA THERAPY TUBESET-E100 SERIES | Parker Hannifin Corp. | 1983-06-30 | Traditional | PDF ↗ |
| K830677 | BLOOD LINE SETS FOR HEMOFILTRATION | Gambro, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K821138 | TS-180 SERIES TUBING SET | Extracorporeal Medical Specialities, Inc. | 1982-05-10 | Traditional | PDF ↗ |
| K820169 | MALE LUER CONNECTOR & HINGED CAP | Extracorporeal Medical Specialities, Inc. | 1982-02-05 | Traditional | PDF ↗ |
| K812685 | ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE | Ericka | 1981-09-29 | Traditional | PDF ↗ |
| K811839 | MEDISYSTEM NEGATIVE PRESSURE | Medisystems Corp. | 1981-09-08 | Traditional | PDF ↗ |
| K810824 | ERIKA HEPARIN INFUSION ADAPTOR | Erika, Inc. | 1981-04-17 | Traditional | PDF ↗ |
| K810823 | ERIKA EXTENSION SETS | Erika, Inc. | 1981-04-17 | Traditional | PDF ↗ |
| K802874 | ARTERIOVENOUS BLOOD TUBING SETS | Extracorporeal Medical Specialities, Inc. | 1980-11-25 | Traditional | PDF ↗ |
| K801211 | COBE HEMOFLO BLOOD TUBING SETS | Cobe Laboratories, Inc. | 1980-07-14 | Traditional | PDF ↗ |
| K801016 | GAMBRO G SERIES BLOOD LINE SETS FOR HEM. | Gambro, Inc. | 1980-05-30 | Traditional | PDF ↗ |
| K792053 | ERIKA NEGATIVE PRESSURE ARTERILA BLOOD | Erika, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K792054 | ERIKA NEGATIVE PRESSURE VENOUS BL SETS | Erika, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K780681 | ARTERIOVENOUS BLOOD TUBING SETS | Extracorporeal Medical Specialities, Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K771693 | CLIRANS BLOOD LINES SET | Terumo America, Inc. | 1977-09-20 | Traditional | PDF ↗ |
| K761326 | ARTERIOVENOUS BLOOD TUBING SETS | Extracorporeal Medical Specialities, Inc. | 1977-01-10 | Traditional | PDF ↗ |
Product code FJK · Class II · Gastroenterology, Urology. Data: openFDA.