Product code KOC
- Device name
- Accessories, Blood Circuit, Hemodialysis
- 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 |
|---|---|---|---|
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | NIKKISO CO., LTD. | 2025-05-15 |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | NIKKISO CO., LTD. | 2025-05-15 |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | NIKKISO CO., LTD. | 2023-07-28 |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | NIKKISO CO., LTD. | 2023-06-16 |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 |
| K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 |
| K160749 | CRIT-LINE III Blood Chamber II | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 |
| K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care North America | 2015-11-05 |
| K141997 | CRIT-LINE IV SYSTEM | Fresenius Medical Care | 2015-04-01 |
| K141281 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care Renal Therapies Group, LLC | 2014-08-14 |
| K121599 | CRIT-LINE CLIP (CLIC) | Fresenius Medical Care-North America | 2012-11-09 |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P | NIKKISO CO., LTD. | 2009-03-30 |
| K081740 | HEMOBAND, MODELS HB-NS AND HB-NSXL | Innovations For Access, Inc. | 2009-03-12 |
| K082758 | PRISMAFLO II | Stihler Electronic GmbH | 2008-12-19 |
| K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | Nxstage Medical, Inc. | 2008-07-07 |
| K071909 | PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R | Barkey GmbH & Co. KG | 2007-10-18 |
| K030456 | VASC-ALERT | Vasc-Alert, LLC | 2003-07-11 |
| K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR | Fresenius Medical Care | 2002-10-30 |
| K020103 | PRISMAFLO | Stihler Electronic GmbH | 2002-07-24 |
| K003712 | MODIFICATION TO MALE TO MALE LUER ADAPTER | Molded Products, Inc. | 2001-05-16 |
| K010268 | FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 | Fresenius Medical Care North America | 2001-04-27 |
| K002816 | TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV | Transonic Systems, Inc. | 2000-11-22 |
| K002372 | ACCESS ALERT GAUGE | Medisystems Corp. | 2000-10-25 |
| K994306 | REVERSO | Medisystems Corp. | 2000-03-20 |
| K983707 | JMS DIALYZER PRIMING SET | Jms Co., Ltd. | 1999-01-08 |
| K972206 | NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS | Nipro Medical Corp. | 1997-11-26 |
| K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS | Medisystems Corp. | 1997-08-18 |
| K954676 | NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS | Nissho Corp. | 1997-03-04 |
| K964041 | CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS | Robert R. Stevens | 1997-01-30 |
| K955277 | ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS | Baxter Healthcare Corp | 1996-02-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B144MPC825S0 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2022-10-04 |
| B144MPC8600 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC8500 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC80050 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC8000 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC8750 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC8700 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC8650 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC855NS3751 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-03 |
| B144MPC855NS250PP1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-03 |
| B144MPC855NS250K1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-03 |
| B144MPC855NS250HDPE1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-03 |
| B144MPC855NS2501 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-03 |
| B144MPC855NS375PP1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-03 |
| B144MPC855S250PP3 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-03 |
| B144MPC660S0 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2018-01-05 |
| B144MPC1401 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2018-01-04 |
| B144MPC850160 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2016-12-16 |
| B144MPC850SP0 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2016-12-16 |
| B144MPC8550 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2016-11-03 |
| B066C135E1 | "CONNECTOR, STRAIGHT 3/8"" X 3/8"" W/LUER NO CAP" | NOVOSCI CORP. | 2015-10-13 |
| B066C225E1 | "CONNECTOR, REDUCER 3/16"" X 1/4"" W/LUER NO CAP" | NOVOSCI CORP. | 2015-10-13 |
| B066C475S0 | "CONN, WYE 1/4"" X 3/8"" X 3/8"" W/LL" | NOVOSCI CORP. | 2015-10-09 |
| B066C485S0 | "CONN, WYE 1/2"" X 1/2"" X 3/8"" W/LL" | NOVOSCI CORP. | 2015-10-09 |
| B066C490S0 | "CONNECTOR, Y 1/2"" X 1/2"" X 1/4""" | NOVOSCI CORP. | 2015-10-06 |
| 00840861100316 | CombiSet Twister | Fresenius Medical Care Holdings, Inc. | 2015-09-24 |
| M535NX13730 | NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX13480 | NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX06420 | NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535M89001E0 | Reverso Clamp Flow Reversing Interconnector for Hemodialysis Blood Tubing Set | MEDISYSTEMS CORPORATION | 2015-09-01 |