510(k) · Cleared

Cleared

Renaclear Dialyzer Cleaning System

K991851510(k) TraditionalCleared Aug 30, 199990-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 Aug 30, 1999 as substantially equivalent to K904210 (Minntech Corp., 1990) after a 90-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Aug 30, 1999
Review: 90 days
Class: Class II
Product code: LIF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K904210 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK904210 Renatron II Dialyzer Reprocessing System RS 8330Minntech Corp. · 1990
This deviceK991851 Renaclear Dialyzer Cleaning SystemMinntech Corp. · 1999
Descendant · cites it directly · 0 of its ownK043126 Assist Header CleanerAlcavis International, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K043126Assist Header CleanerAlcavis International, Inc. · 2005 · cites it directly0descendants

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)	K991851	Renaclear Dialyzer Cleaning System	Minntech Corp.	1999	—
+1	K043126	Assist Header Cleaner	Alcavis International, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K991851, 1990–2005Source: 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 2 …in automated dialyzer reprocessing systems currently in distribution in the United States. The Renatron® II Dialyzer Reprocessing System KA91861 p.2/> (K904210) pre-clean cycle is intended to pre-clean multiple-use dialyzers prior to testing and sterilization. Summary 4.1 Minntech Corpor…	Minntech Corp.	1990	—

Also cleared against K904210: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K043126	Assist Header Cleaner	Alcavis International, Inc.	2005	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?

Its one ancestor has no recall.
Of its descendants, K043126 (Alcavis International, Inc., 2005) has gone furthest, with 0 descendants of its own.
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 RenaClear™ Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers prior to being reprocessed in an approved dialyzer reprocessing program.

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/K991851 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991851: Renaclear Dialyzer Cleaning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991851

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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