# K970446: Drake Willock System & Altra Touch 1000 Dialysis Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Althin Medical AB an Affiliate of Baxter Intl
- Decided: Jun 2, 1997 after 117 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910215 (1991). 7 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 19 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.
- K955384: Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen Option, Althin Medical AB an Affiliate of Baxter Intl (1997) Summary page 1.
- K924167: Crit-Line, Noninvasive Medical Technology Corp. (1993) Summary page 1.
- K950942: Crit-Line Hematocrit Alert, In-Line Diagnostics Corp. (1995) Summary page 1.
- K953875: Crit-Line Hematocrit Alert (Modification), In-Line Diagnostics Corp. (1996) Summary page 1.

## Most influential descendants
- K993064: Prisma CFM (Continuous Fluid Management System) (1999), 9 descendants of its own
- K021615: Baxter Accura System, Model 5M5660 (2002), 8 descendants of its own
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets (2004), 4 descendants of its own
- K080519: Prismaflex M150 Set (2008), 1 descendant of its own
- K070320: Edwards Aquarius Hemofiltration System, Model Abm 01 (2007), 1 descendant of its own

## Recalls of this device
- Sep 19, 2011 · Not classified · Z-0173-2012: The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
- Jun 21, 2006 · Not classified · Z-1253-06: The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.
- Jun 14, 2005 · Not classified · Z-1394-05: Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Ad
- Dec 14, 2004 · Not classified · Z-0367-05: Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
- Feb 20, 2004 · Not classified · Z-0583-04: These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.

## Indications for use
The intended use of the device is 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 use in conjunction with a hollow fiber or parallel plate dialyzer. The intended use of this device is to monitor Hematocrit, Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation. The device is intended to be used as an integrated option of the System 1000° Dialysis Delivery System. 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 the Crit-Line disposable Blood Chamber. The Blood Chamber is a non reusable device. To provide the medical professional with a means of monitoring Hematocrit, Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation during hemodialysis treatment.

Source page: https://510kreport.com/device/K970446
Methodology: https://510kreport.com/methodology