# K910215: Drake Willock System 1000 Dialysate Delivery Syst

- Pathway: 510(k) (Traditional)
- Applicant: Cd Medical, Inc.
- Decided: Apr 9, 1991 after 82 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 4 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K954987: Altratouch 1000 Hemodialysis Delivery System (1996), 13 descendants of its own
- 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

## Recalls of this device
- 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.
- Feb 24, 2006 · Not classified · Z-0766-06: The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts beco
- Nov 18, 2005 · Not classified · Z-0347-06: Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air embo
- May 28, 2003 · Not classified · Z-0395-05: The air detector may not detect air bubbles consistently at the selected limit.
- Mar 20, 2003 · Not classified · Z-0833-03: The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.

Source page: https://510kreport.com/device/K910215
Methodology: https://510kreport.com/methodology