# K954987: Altratouch 1000 Hemodialysis Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Althin Medical AB an Affiliate of Baxter Intl
- Decided: Aug 8, 1996 after 282 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910215 (1991). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 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 2.

## Most influential descendants
- K970446: Drake Willock System & Altra Touch 1000 Dialysis Delivery System (1997), 11 descendants of its own
- 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

## Recalls of this device
- Aug 31, 2009 · Not classified · Z-0179-2010: When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's manua

## Indications for use
To provide hemodialysis treatment to patients with acute or chronic renal failure.

Source page: https://510kreport.com/device/K954987
Methodology: https://510kreport.com/methodology