# K041683: B. Braun Bicarbonate Dialysate

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 27, 2004 after 67 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864265 (1987). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013448: Prismasate, Gambro Renal Products (2002) Summary page 1.

## Most influential descendants
- K052393: B. Braun Modified Bicarbonate Dialysate (2005), 6 descendants of its own
- K120333: Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy (2012), 5 descendants of its own
- K162887: PrismaSATE (2017), 4 descendants of its own
- K233159: pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 (2023), 3 descendants of its own
- K233950: pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) (2024), 2 descendants of its own

## Indications for use
B. Braun Bicarbonate Dialysate is indicated for use with renal replacement therapy systems that utilize sterile bicarbonate dialysate.

Source page: https://510kreport.com/device/K041683
Methodology: https://510kreport.com/methodology