# K071518: Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Medizintechnologie GmbH
- Decided: Aug 17, 2007 after 74 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have 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) Hemoflow F5: named in the summary without a submission number
- (no number) Hemoflow F6: named in the summary without a submission number
- (no number) Hemoflow F7: named in the summary without a submission number
- (no number) Hemoflow F8: named in the summary without a submission number
- (no number) Hemoflow F 50 NR: named in the summary without a submission number
- (no number) Hemoflow F 60 A: named in the summary without a submission number
- (no number) Hemoflow F 60 B: named in the summary without a submission number
- (no number) Hemoflow F 70 A: named in the summary without a submission number
- (no number) Hemoflow F 70 B: named in the summary without a submission number
- (no number) Hemoflow F 70 NR: named in the summary without a submission number
- (no number) Hemoflow F 80 A: named in the summary without a submission number
- (no number) Hemoflow F 80 B: named in the summary without a submission number
- (no number) Optiflux 200 A: named in the summary without a submission number

## Most influential descendants
- K100334: Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811 (2010), 1 descendant of its own
- K170574: Diacap Pro Dialyzer (2017), 0 descendants of its own
- K143482: xevonta dialyzer (2016), 0 descendants of its own

## Indications for use
Diacap LOPS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers are designed for single use in acute and chronic hemodialysis.

Source page: https://510kreport.com/device/K071518
Methodology: https://510kreport.com/methodology