# K052764: Diacap Ultra Dialysis Fluid Filter

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Medizintechnologie GmbH
- Decided: Jun 9, 2006 after 252 days
- Product code: FKQ (System, Dialysate Delivery, Central Multiple Patient)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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: 2 generations back to K945136 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993806: Dialguard Endotoxin Removal Device, Clarigen, Inc. (2000) Summary page 1.
- K003957: Diaclear Ultrafilter, Gambro Renal Products (2001) Summary page 1.
- K983126: Fiberflo Hollow Fiber Capsule Water Filters, Minntech Corp. (1999) Summary page 1.

## Recalls of this device
- Mar 1, 2013 · Class II · Z-1183-2013: There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).

## Indications for use
The Diacap Ultra Dialysis Fluid Filter is intended to filter bacteria and endotoxins from dialysate.

Source page: https://510kreport.com/device/K052764
Methodology: https://510kreport.com/methodology