# K963440: Dialog Dialysis Machine

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Medical AG
- Decided: Jun 26, 1998 after 665 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: 6 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K850569 (1985). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854367: HD-Secura Hemadialysis Machine, Organon Teknika Corp. (1985) Summary page 1.
- K850569: BSM 2000 Dialysis Machine - Modified, Organon Teknika Corp. (1985) Summary page 1.
- K880459: 480 High-Flow Ultrafiltration Control Dialysate, Cd Medical, Inc. (1988) Summary page 1.

## Most influential descendants
- 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
- K042938: Gambro Prismaflex HF1000 and HF1400 Sets (2005), 1 descendant of its own
- K220281: multiFiltratePRO System (2022), 0 descendants of its own
- K212216: Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set (2022), 0 descendants of its own

## Recalls of this device
- Apr 1, 2016 · Class I · Z-1531-2016: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Apr 1, 2016 · Class I · Z-1534-2016: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Apr 1, 2016 · Class I · Z-1532-2016: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Apr 1, 2016 · Class I · Z-1535-2016: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Apr 1, 2016 · Class I · Z-1533-2016: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Apr 1, 2016 · Class I · Z-1536-2016: Potential leakage of conductivity sensors of the Dialog Dialysis machines.

## Indications for use
Volume controlled ultrafiltration and infusion for treatment of renal failure or toxic conditions. This device may be used for high flux hemodialysis.

Source page: https://510kreport.com/device/K963440
Methodology: https://510kreport.com/methodology