# K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter

- Pathway: 510(k) (Traditional)
- Applicant: Nephros, Inc.
- Decided: Apr 27, 2012 after 260 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: 3 generations back to K955592 (1997). 24 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050603: Olpur Dialyzer, Model HD 190, Nephros, Inc. (2005) Summary page 1.
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub, Aksys, Ltd. (2002) Summary page 1.
- K090885: Nephros, Inc., Dsu Dual Stage Ultrafilter, Nephros, Inc. (2009) Summary page 1.
- K945136: Renaguard Dialysate Filter, Minntech Corp. (1995) Summary page 2.
- K003957: Diaclear Ultrafilter, Gambro Renal Products (2001) Summary page 2.
- K974090: 95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers, Fresenius Medical Care North America (1998) Summary page 2.
- K983126: Fiberflo Hollow Fiber Capsule Water Filters, Minntech Corp. (1999) Summary page 2.
- K033301: IV Administration and Connect Sets, Codan US Corp. (2004) Summary page 2.
- K072024: Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693, Nipro Medical Corp. (2007) Summary page 2.

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

## Indications for use
The OLP~r H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLP~r MID 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPOr MID 220 Hemodiafilter is only to be used with the OLpair H2H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician. The OLP~r H2H Hemodiafiltration (HDF) Module works in conjunction with a qualified host (UF controlled) hemodialysis machine and it's accessories (i.e., bloodlines; dialysate, concentrates, etc.), the H2H Module accessories (water and substitution fluid filters, infusion / rinse line, and optional blood extension line), appropriately prepared water and ultrapure dialysate for hemodialysis, and a high permeability hernodialyzerI hernodiafilter (i.e., the OLP~ir MD 220 Hemodiafilter).

Source page: https://510kreport.com/device/K112314
Methodology: https://510kreport.com/methodology