# K210575: HDF Assist Mudule, HDF Infusion Set and Substitution Filter

- Pathway: 510(k) (Traditional)
- Applicant: Nephros
- Decided: May 13, 2022 after 441 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
Longest line of descent: 4 generations back to K955592 (1997). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter, Nephros, Inc. (2012) Summary page 4.

## Most influential descendants
- K233557: HemoCare Hemodialysis System (2024), 0 descendants of its own

## Indications for use
The HDF Assist Module is indicated for use, with the Fresenius 2008K, 2008K2, and 2008T dialysis machines, for treatment of adult patients with acute or chronic renal failure or whenever hemodiafiltration is prescribed by a physician. The HDF Assist Module works in conjunction with a qualified host high permeability (UF controlled) hemodialysis machine and its accessories (i.e., bloodlines, dialysate, concentrates, etc.), the HDF Assist Module accessories (HDF Infusion Set and Substitution Filter), appropriately purified water and ultrapure dialysate for hemodialysis, and a high permeability hemodialyzer / hemodiafilter (i.e., the OLPūr™ MD 220 Hemodiafilter).

Source page: https://510kreport.com/device/K210575
Methodology: https://510kreport.com/methodology