510(k) · Cleared

Cleared

Renaclean SH Dialyzer Cleaning System

K033505510(k) TraditionalCleared Apr 27, 2004174-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 Apr 27, 2004 as substantially equivalent to K904210 (Minntech Corp., 1990) after a 174-day review. Its family tree reaches back 1 generation to 1990.

Decided: Apr 27, 2004
Review: 174 days
Class: Class II
Product code: LIF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K904210 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK904210 Renatron II Dialyzer Reprocessing System RS 8330Minntech Corp. · 1990
This deviceK033505 Renaclean SH Dialyzer Cleaning SystemMinntech Corp. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904210	Renatron II Dialyzer Reprocessing System RS 8330	Minntech Corp.	1990	—
0 (this device)	K033505	Renaclean SH Dialyzer Cleaning System	Minntech Corp.	2004	—

FIG. 1 — Lineage of K033505, 1990–2004Source: 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 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K904210	Renatron II Dialyzer Reprocessing System RS 8330 Summary page 1 …cleaning cycles in automated dialyzer reprocessing systems currently in distribution in the United States. The Renatron II Dialyzer Reprocessing System (K9042 10) pre-clean cycle is intended to pre-clean multiple-use dialyzers prior to testing and sterilization. 4. S…	Minntech Corp.	1990	—

Also cleared against K904210: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
4 other devices also cite its predicate K904210.

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	—

What is it indicated for?

Minntech Corporation's RenaClean T M SH Dialyzer Cleaning System is used to facilitate

the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to

being reprocessed on a Renatron®Dialyzer Reprocessing System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033505 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033505: Renaclean SH Dialyzer Cleaning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033505

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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