Drake Willock Central Dialysate Delivery System
FDA 510(k) K862304 · Cd Medical, Inc.
510(k) numberK862304
Submission
- Device name
- Drake Willock Central Dialysate Delivery System
- Applicant
- Cd Medical, Inc.
Miami Lakes, FL, US - Received
- June 17, 1986
- Decision date
- September 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKQ – System, Dialysate Delivery, Central Multiple Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052764 | Diacap Ultra Dialysis Fluid FilterFKQ · Traditional | B. Braun Medizintechnologie GmbH | 06/09/2006SE |
| K893612 | Two Tank Dissolution ModuleFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 07/24/1989SE |
| K874084 | Multiple Artificial Kidney Systems (Maks) #IdmFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 04/27/1988SE |
| K873421 | Kawasumi A.V. Fistula SetFKQ · Traditional | Kawasumi Laboratories Co., Ltd. | 10/09/1987SE |
| K870889 | Acid Fuchsin SolutionsFKQ · Traditional | D.R.G. Scientific Industries | 07/08/1987SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | Renal Systems, Inc. | 06/09/1987SE |
| K864635 | Four Tank Dissolution ModuleFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 01/13/1987SE |
| K861472 | Maks Central Delivery Systems Models 11-425/11-445FKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 07/10/1986SE |
| K852359 | Amuchina/Dialyzer DisinfectantFKQ · Traditional | Amuchina Intl., Inc. | 05/13/1986SE |
| K860336 | Hemodialysis Concentrates and Related ProductsFKQ · Traditional | Breem Laboratories | 03/04/1986SE |
More from Breem Laboratories
| 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 |
| K864784 | Seraflo(Tm) Bloodlines for HemodialysisFJK · Traditional | 01/20/1987SE |
| 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 Drake Willock Central Dialysate Delivery System cleared by the FDA?
Drake Willock Central Dialysate Delivery System (K862304) received a 510(k) decision of Substantially Equivalent on September 9, 1986, 84 days after the submission was received.
What is the product code of K862304?
The FDA product code is FKQ – System, Dialysate Delivery, Central Multiple Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.