Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
FDA 510(k) K230514 · Nikkiso Co., Ltd.
510(k) numberK230514
Submission
- Device name
- Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
- Applicant
- Nikkiso Co., Ltd.
Shibuya-Ku, JP - Received
- February 24, 2023
- Decision date
- June 16, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOC – Accessories, Blood Circuit, Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KOC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-EKOC · Traditional | Nikkiso Co., Ltd. | 07/28/2023SE |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…KOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/18/2020SE |
| K172238 | CAREline Airless Hemodialysis Blood Tubing SetsKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/14/2017SE |
| K160749 | CRIT-LINE III Blood Chamber IIKOC · Special | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2016SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | Fresenius Medical Care North America | 11/05/2015SE |
| K141997 | Crit-Line IV SystemKOC · Traditional | Fresenius Medical Care | 04/01/2015SE |
| K141281 | Crit-Line Clip (Clic) Blood ChamberKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/14/2014SE |
| K121599 | Crit-Line Clip (Clic)KOC · Traditional | Fresenius Medical Care-North America | 11/09/2012SE |
More from Fresenius Medical Care-North America
| 510(k) | Device | Decision |
|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | 05/15/2025SE |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | 05/15/2025SE |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)KDI · Traditional | 05/15/2025SE |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-EKOC · Traditional | 07/28/2023SE |
| K152938 | DBB-06 Hemodialysis Delivery SystemKDI · Traditional | 03/18/2016SE |
| K091978 | DBB-06 Hemodialysis Delivery SystemKDI · Traditional | 03/25/2010SE |
| K082719 | Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-PKOC · Traditional | 03/30/2009SE |
| K061519 | Modification to DBB-05 Hemodialysis Delivery SystemKDI · Special | 09/28/2007SE |
| K953996 | Nikkiso Co, Ltd., FLX10GW, 12GW, 15GW, 18GW & 21GW HemodialyzersKDI · Traditional | 03/19/1997SE |
| K803068 | Nikkiso ND-14 Parallel Flow DialyzerFJG · Traditional | 03/04/1981SE |
Questions and answers
When was Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series cleared by the FDA?
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series (K230514) received a 510(k) decision of Substantially Equivalent on June 16, 2023, 112 days after the submission was received.
What is the product code of K230514?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.