# K974090: 95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Aug 27, 1998 after 302 days
- Product code: MSE (Hemodialyzer, Re-Use, Low Flux)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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
Hemoflow dialyzers are designed for acute and chronic hemodialysis. Hemoflow dialyzers are also appropriate for single or multiple use when reprocessed with 1.5% Citric Acid/95°C.

Source page: https://510kreport.com/device/K974090
Methodology: https://510kreport.com/methodology