Drake Willock Reverse Osmosis Water Treatment Syst
FDA 510(k) K894106 · Cd Medical, Inc.
510(k) numberK894106
Submission
- Device name
- Drake Willock Reverse Osmosis Water Treatment Syst
- Applicant
- Cd Medical, Inc.
Miami Lakes, FL, US - Received
- June 9, 1989
- Decision date
- November 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FIP – Subsystem, Water Purification
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K250471 | AquaC UNO HFIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 11/14/2025SE |
| K251851 | DIASAFEplusUS (F00013010)FIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/09/2025SE |
| K252181 | AquaAFIP · Traditional | Fresenius Medical Care North America | 09/09/2025SE |
| K250514 | UPT Series Medical RO Water Treatment SystemFIP · Special | Specialty Water Technologies, Inc. | 03/17/2025SE |
| K232953 | AquaBplus; AquaB LITEFIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2024SE |
| K223479 | AQUAbase nXFIP · Traditional | B.Braun Medical, Inc. | 08/16/2023SE |
| K231410 | RenaPure Endotoxin Retentive FilterFIP · Traditional | Evoqua Water Technologies, LLC | 07/19/2023SE |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF)FIP · Special | AmeriWater, LLC | 02/13/2023SE |
| K213507 | AquaAFIP · Traditional | Fresenius Medical Care Rental Therapies Group, LLC | 07/27/2022SE |
| K211035 | U9000 Plus UltrafilterFIP · Traditional | Baxter Healthcare Corporation | 10/19/2021SE |
More from Baxter Healthcare Corporation
| 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 |
| 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 |
| 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 Drake Willock Reverse Osmosis Water Treatment Syst cleared by the FDA?
Drake Willock Reverse Osmosis Water Treatment Syst (K894106) received a 510(k) decision of Substantially Equivalent on November 8, 1989, 152 days after the submission was received.
What is the product code of K894106?
The FDA product code is FIP – Subsystem, Water Purification, a Class II (moderate risk) device regulated under 21 CFR 876.5665.