# K083460: Dialog with Adimea Option

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Avitum AG
- Decided: Feb 18, 2010 after 454 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: 8 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dialog+® Hemodialysis System: named in the summary without a submission number

## Most influential descendants
- K152938: DBB-06 Hemodialysis Delivery System (2016), 1 descendant of its own
- K242155: DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (2025), 0 descendants of its own
- K182940: Surdial DX Hemodialysis System (2019), 0 descendants of its own

## Recalls of this device
- Jan 28, 2022 · Class II · Z-0873-2022: Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficie
- Jan 28, 2022 · Class II · Z-0872-2022: Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficie
- 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
This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician. The following types ‘of renal replacement therapy can be carried out with the Dialog+ System: Hemodialysis (HD) with or without phases of pure ultrafiltration — * High flux hemodialysis * Low flux hemodialysis

Source page: https://510kreport.com/device/K083460
Methodology: https://510kreport.com/methodology