# K072908: Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Feb 4, 2008 after 115 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- 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: 5 generations back to K864265 (1987). 9 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 16 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.
- K042045: Nxstage Pureflow-B Solution, Nxstage Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K243786: Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (2025), 1 descendant of its own

## Recalls of this device
- May 23, 2016 · Class II · Z-2049-2016: Presence of leaks near top of the PrismaSate bags

## Indications for use
Gambro PrismaSateTM solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Source page: https://510kreport.com/device/K072908
Methodology: https://510kreport.com/methodology