# K964922: Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Althin Medical AB an Affiliate of Baxter Intl
- Decided: May 21, 1997 after 163 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910215 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910215: Drake Willock System 1000 Dialysate Delivery Syst, Cd Medical, Inc. (1991) Summary page 1.
- K954987: Altratouch 1000 Hemodialysis Delivery System, Althin Medical AB an Affiliate of Baxter Intl (1996) Summary page 1.

## Most influential descendants
- K013562: Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys 1000, L3 with N100 Arm, 4B Software (2002), 0 descendants of its own

## Indications for use
The indications for use of the device are to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis. The device is intended to be used by trained operators when prescribed by a physician. The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer. The auto start option is intended to allow up to a three day delayed start of the fluid path heat clean or rinse cycle.

Source page: https://510kreport.com/device/K964922
Methodology: https://510kreport.com/methodology