Single Needle Hemodialysis (BFC-142)
FDA 510(k) K761082 · Sorensen Research
510(k) numberK761082
Submission
- Device name
- Single Needle Hemodialysis (BFC-142)
- Applicant
- Sorensen Research
Mchenry, IL, US - Received
- November 19, 1976
- Decision date
- December 6, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K833674 | Accurate Measurement Device Kg-AmdGCX · Traditional | 01/25/1984SE |
| K833673 | Accurate Measurement Device Ez-AmdGCX · Traditional | 12/29/1983SE |
| K833096 | Transducer Dome DS106DRS · Traditional | 11/03/1983SE |
| K833095 | Transducer Dome SD105DRS · Traditional | 11/03/1983SE |
| K833094 | Transducer Dome SD104DRS · Traditional | 11/03/1983SE |
| K832957 | Flow-Directed Heparin Coated ThermodilDYG · Traditional | 09/29/1983SE |
| K831506 | Disp. Transducer W/Monitoring Kit TransDRS · Traditional | 08/12/1983SE |
| K831939 | Tall Floor Stand TFS-01GCX · Traditional | 07/19/1983SE |
| K831505 | Thoracic Gauge #TG-60 -Vacuum RegulatorKDP · Traditional | 07/12/1983SE |
| K820706 | Waterless Seal & Vacuum RegulatorKDP · Traditional | 04/09/1982SE |
Questions and answers
When was Single Needle Hemodialysis (BFC-142) cleared by the FDA?
Single Needle Hemodialysis (BFC-142) (K761082) received a 510(k) decision of Substantially Equivalent on December 6, 1976, 17 days after the submission was received.
What is the product code of K761082?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.