# K955384: Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen Option

- Pathway: 510(k) (Traditional)
- Applicant: Althin Medical AB an Affiliate of Baxter Intl
- Decided: Jan 10, 1997 after 415 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: 1 generation back to K873279 (1987). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873279: 8810 Pump-Pump Single Needle Device, Cd Medical, Inc. (1987) Summary page 1.
- (no number) Drake Willock 8806 Single Needle Device: named in the summary without a submission number
- (no number) Fresenius A 2008 D Single Needle Device: named in the summary without a submission number
- (no number) Hospal BSM 22: named in the summary without a submission number

## 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

## Indications for use
Single Needle Single Lumen Dialysis is indicated for use when a single venipuncture is chosen for use in chronic or acute hemodialysis treatments.

Source page: https://510kreport.com/device/K955384
Methodology: https://510kreport.com/methodology