510(k) · Cleared

Cleared

Renatron II Dialyzer Reprocessing System RS 8330

K904210510(k) TraditionalCleared Nov 27, 199076-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

Minntech Corp. · LIF Dialyzer Reprocessing System

Cleared on Nov 27, 1990 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.

Decided: Nov 27, 1990
Review: 76 days
Class: Class II
Product code: LIF
Recalls: None
Predicates: 0

18 later devices descend from it, 5 citing it directly.

This deviceK904210 Renatron II Dialyzer Reprocessing System RS 8330Minntech Corp. · 1990
Descendant · cites it directly · 12 of its ownK010131 PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…Aksys, Ltd. · 2002 · Recalled
Descendant · 2 generations on · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
Descendant · 2 generations on · 5 of its ownK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
Descendant · 3 generations on · 3 of its ownK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

1999high 2 (2005) · low 0 (2000)2026

Most influential descendants

Showing 5 of 18 · See all

K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Aksys, Ltd. · 2002 · cites it directly12descendants
K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · 2 generations on5descendants
K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005 · 2 generations on5descendants
K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006 · 3 generations on3descendants
K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K904210	Renatron II Dialyzer Reprocessing System RS 8330	Minntech Corp.	1990	—
+1	K010131	PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…	Aksys, Ltd.	2002	1
+2	K112314	Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter	Nephros, Inc.	2012	—
+2	K043436	Nxstage Dialysate Preparation Module, Model NX0269	Nxstage Medical, Inc.	2005	—
+3	K060296	Nxstage Dialysate Preparation Module	Nxstage Medical, Inc.	2006	—
+2	K231534	5008X Hemodialysis System	Fresenius Medical Care	2024	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2003	1	0
2004	1	0
2005	2	0
2006	1	0
2008	2	0
2010	1	0
2011	1	0
2012	1	0
2014	1	0
2022	1	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K904210, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in LIF? 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (18)

See all 18

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K010131	PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…	Aksys, Ltd.	2002	12
K024076	Maky 21.1 Dialyzer Reprocessing System	Hdc Maquinolas, LLC	2003	1
K991851	Renaclear Dialyzer Cleaning System	Minntech Corp.	1999	1
K091360	Clearflux Dialyzer Reprocessing System	Novaflux Technologies	2010	0
K033505	Renaclean SH Dialyzer Cleaning System	Minntech Corp.	2004	0

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, K010131 (Aksys, Ltd., 2002) has gone furthest, with 12 descendants of its own.

How does its category compare?

All LIF devices

LIF Dialyzer Reprocessing System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIF

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIF

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

Recalls per year · LIF

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LIF

1in 2017

2007high 3 (2007) · low 0 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	3
2008	0	—	0	1
2009	0	—	1	0
2010	1	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

https://510kreport.com/device/K904210 · printed Nov 5, 2026

Cite this page

510(k) Report. “K904210: Renatron II Dialyzer Reprocessing System RS 8330.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904210

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026