510(k) · Cleared

Cleared

95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers

K974090510(k) TraditionalCleared Aug 27, 1998302-day reviewClass II21 CFR 876.5820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fresenius Medical Care North America · MSE Hemodialyzer, Re-Use, Low Flux

Cleared on Aug 27, 1998 after a 302-day review. The FDA summary names no predicate by number. 6 later devices descend from it.

Decided: Aug 27, 1998
Review: 302 days
Class: Class II
Product code: MSE
Recalls: None
Predicates: 0

6 later devices descend from it, 1 citing it directly.

This deviceK974090 95 C/1.5 Citric Acid Heat Processing of Polysulfone DialyzersFresenius Medical Care North America · 1998
Descendant · cites it directly · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
Descendant · 3 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
Descendant · 2 generations on · 1 of its ownK210575 HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022
Descendant · 4 generations on · 0 of its ownK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012high 2 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all

K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · cites it directly5descendants
K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants
K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022 · 2 generations on1descendant
K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K974090	95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers	Fresenius Medical Care North America	1998	—
+1	K112314	Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter	Nephros, Inc.	2012	—
+2	K231534	5008X Hemodialysis System	Fresenius Medical Care	2024	1
+3	K243505	5008X Hemodialysis System	Fresenius Medical Care Renal Therapies Group, LLC	2025	6
+2	K210575	HDF Assist Mudule, HDF Infusion Set and Substitution Filter	Nephros	2022	—
+4	K251851	DIASAFEplusUS (F00013010)	Fresenius Medical Care Renal Therapies Group, LLC	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2022	1	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K974090, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MSE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112314	Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter	Nephros, Inc.	2012	5

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K112314 (Nephros, Inc., 2012) has gone furthest, with 5 descendants of its own.

How does its category compare?

All MSE devices

MSE Hemodialyzer, Re-Use, Low Flux: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSE

FDA has decided no MSE device since 2007.

Median 510(k) review, days · MSE

Too few MSE 510(k)s in any year since 2007 to give a median.

Recalls per year · MSE

No recall names MSE since 2007.

Adverse event reports per year · MSE

5in 2014

2007high 6 (2010) · low 0 (2007)2025

MAUDE reports naming product code MSE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	6
2011	—	5
2012	—	0
2013	—	0
2014	—	5
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974090 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974090: 95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974090

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026