# K251851: DIASAFEplusUS (F00013010)

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Oct 9, 2025 after 115 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K921456 (1994). 59 ancestors in all.
No later device cites it as a predicate yet.
4 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243505: 5008X Hemodialysis System, Fresenius Medical Care Renal Therapies Group, LLC (2025) Summary page 5.

## Indications for use
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system). The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively. The DIASAFE®plusUS can only be used with Fresenius Medical Care hemodialysis machines fitted for use with the DIASAFE®plusUS.

Source page: https://510kreport.com/device/K251851
Methodology: https://510kreport.com/methodology