CAREline Airless Hemodialysis Blood Tubing Sets
FDA 510(k) K172238 · Fresenius Medical Care Renal Therapies Group, LLC
510(k) numberK172238
Submission
- Device name
- CAREline Airless Hemodialysis Blood Tubing Sets
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
Waltham, MA, US - Received
- July 26, 2017
- Decision date
- December 14, 2017
- 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 |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…KOC · Traditional | Nikkiso Co., Ltd. | 06/16/2023SE |
| 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 |
| 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 |
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Questions and answers
When was CAREline Airless Hemodialysis Blood Tubing Sets cleared by the FDA?
CAREline Airless Hemodialysis Blood Tubing Sets (K172238) received a 510(k) decision of Substantially Equivalent on December 14, 2017, 141 days after the submission was received.
What is the product code of K172238?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.