Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System
FDA 510(k) K964922 · Althin Medical AB an Affiliate of Baxter Intl
510(k) numberK964922
Submission
- Device name
- Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
Portland, OR, US - Received
- December 9, 1996
- Decision date
- May 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KDI
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| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/15/2026SE |
| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K990643 | PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015KDI · Traditional | 12/07/1999SE |
| K970681 | Altra Nova 200 HemodialyzerMSF · Traditional | 07/23/1998SE |
| K970679 | Altra Flux 200 HemodialyzerMSF · Traditional | 07/23/1998SE |
| K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemKDI · Traditional | 06/02/1997SE |
| K955384 | Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen OptionKDI · Traditional | 01/10/1997SE |
| K962309 | Alternate Encapsulating Resin System for Mca HemodialyzersFJI · Traditional | 12/27/1996SE |
| K954987 | Altratouch 1000 Hemodialysis Delivery SystemKDI · Traditional | 08/08/1996SE |
| K952983 | Altr Nova 110 HemodialyzerKDI · Traditional | 10/05/1995SE |
| K952982 | Altrex 110 HemodialyzerKDI · Traditional | 10/05/1995SE |
| K952978 | Altra Flux 110 HemodialyzerKDI · Traditional | 10/05/1995SE |
Questions and answers
When was Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System cleared by the FDA?
Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System (K964922) received a 510(k) decision of Substantially Equivalent on May 21, 1997, 163 days after the submission was received.
What is the product code of K964922?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.