# K182367: DIASAFEplusUS

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Jan 10, 2019 after 132 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: 1 generation back to K944767 (1995). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944767: Dialysis Machine with Dialysate Ultrafilter, Fresenius USA, Inc. (1995) Summary page 4.

## Most influential descendants
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K251851: DIASAFEplusUS (F00013010) (2025), 0 descendants of its own

## Indications for use
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate from pre-treated 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 dialysis machines fitted for use with DIASAFE®plusUS.

Source page: https://510kreport.com/device/K182367
Methodology: https://510kreport.com/methodology