Seraflo(Tm) Bloodlines for Hemodialysis
FDA 510(k) K864784 · Cd Medical, Inc.
510(k) numberK864784
Submission
- Device name
- Seraflo(Tm) Bloodlines for Hemodialysis
- Applicant
- Cd Medical, Inc.
Miami Lakes, FL, US - Received
- December 8, 1986
- Decision date
- January 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124)FJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 05/15/2026SE |
| K251341 | VITAL Tubing Sets for HemodialysisFJK · Traditional | Vital Healthcare Sdn. Bhd. | 01/16/2026SE |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)FJK · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 10/02/2025SE |
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 )FJK · Special | Diality, Inc. | 12/20/2024SE |
| K213992 | CombiSet Hemodialysis Blood Tubing SetFJK · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/31/2023SE |
| K210782 | Tablo CartridgeFJK · Traditional | Outset Medical, Inc. | 11/26/2021SE |
| K202796 | SANSIN Tubing Sets for HemodialysisFJK · Traditional | Jiangxi Sanxin Medtec Co., Ltd. | 09/06/2021SE |
| K201866 | NovaLine Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 03/10/2021SE |
| K171952 | Dimesol Tubing Sets for HemodialysisFJK · Traditional | Dimesol, Inc. | 03/30/2018SE |
| K161582 | DORA Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/16/2017SE |
More from Bain Medical Equipment (Guangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K925654 | CD Home Dialyservice Hemodialysis TrayKOC · Traditional | 03/30/1994SEKD |
| K910215 | Drake Willock System 1000 Dialysate Delivery SystFKP · Traditional | 04/09/1991SE |
| K901520 | Wurtz Choley Clip (TM)GBZ · Traditional | 06/26/1990SE |
| K894106 | Drake Willock Reverse Osmosis Water Treatment SystFIP · Traditional | 11/08/1989SE |
| K884353 | Ultrx(Tm) 850 Artificial KidneyKDI · Traditional | 12/08/1988SE |
| K880459 | 480 High-Flow Ultrafiltration Control DialysateFKP · Traditional | 04/13/1988SE |
| K873279 | 8810 Pump-Pump Single Needle DeviceFIF · Traditional | 10/23/1987SE |
| K862304 | Drake Willock Central Dialysate Delivery SystemFKQ · Traditional | 09/09/1986SE |
| K853513 | Drake Willock 480 Uf Control Idalysate Delivery SyFKP · Traditional | 11/06/1985SE |
| K844185 | Modified C-DakKOC · Traditional | 01/03/1985SE |
Questions and answers
When was Seraflo(Tm) Bloodlines for Hemodialysis cleared by the FDA?
Seraflo(Tm) Bloodlines for Hemodialysis (K864784) received a 510(k) decision of Substantially Equivalent on January 20, 1987, 43 days after the submission was received.
What is the product code of K864784?
The FDA product code is FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, a Class II (moderate risk) device regulated under 21 CFR 876.5820.