# K050603: Olpur Dialyzer, Model HD 190

- Pathway: 510(k) (Traditional)
- Applicant: Nephros, Inc.
- Decided: Jun 9, 2005 after 92 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: 2 generations back to K955592 (1997). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters, Gambro Healthcare (1999) Summary page 1.
- K001250: Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models), Asahi Medical Co., Ltd. (2000)

## Most influential descendants
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), 5 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K210575: HDF Assist Mudule, HDF Infusion Set and Substitution Filter (2022), 1 descendant of its own
- K251851: DIASAFEplusUS (F00013010) (2025), 0 descendants of its own

## Indications for use
The OLpjr TM HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.

Source page: https://510kreport.com/device/K050603
Methodology: https://510kreport.com/methodology