510(k) · Cleared

Cleared

Maky 21.1 Dialyzer Reprocessing System

K024076510(k) TraditionalCleared Sep 26, 2003290-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

Hdc Maquinolas, LLC · LIF Dialyzer Reprocessing System

Cleared on Sep 26, 2003 as substantially equivalent to K904210 (Minntech Corp., 1990) and 1 other predicate after a 290-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided: Sep 26, 2003
Review: 290 days
Class: Class II
Product code: LIF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K834447 (1984). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK834447 Echo MM1000Mesa Medical, Inc. · 1984
This deviceK024076 Maky 21.1 Dialyzer Reprocessing SystemHdc Maquinolas, LLC · 2003
Descendant · cites it directly · 0 of its ownK091360 Clearflux Dialyzer Reprocessing SystemNovaflux Technologies · 2010

Most influential descendants

Showing 1 of 1 · See all

K091360Clearflux Dialyzer Reprocessing SystemNovaflux Technologies · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K834447	Echo MM1000	Mesa Medical, Inc.	1984	—
0 (this device)	K024076	Maky 21.1 Dialyzer Reprocessing System	Hdc Maquinolas, LLC	2003	—
+1	K091360	Clearflux Dialyzer Reprocessing System	Novaflux Technologies	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K024076, 1984–2010Source: 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? (2)

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	Minntech Corp.	1990	—
*	K834447	Echo MM1000 Summary page 1 …d to be . substantially equivalent to a legally marketed (preAmendment) device on November 27, 1990. Mesa Medical, Inc. Echo MMl 000 Dialyzer Reprocessing System (K834447), determined to be substantially equivalent to a legally marketed (preAmendment) device on December 16, 1983. Descriptive Sum…	Mesa Medical, Inc.	1984	—

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
K091360	Clearflux Dialyzer Reprocessing System	Novaflux Technologies	2010	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?

None of the 2 ancestors has a recall.
Of its descendants, K091360 (Novaflux Technologies, 2010) 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?

The MAKY 21. I is indicated for use in automating the in-vitro rinsing, cleaning, testing and disinfection of hollow fiber type hemodialyzers in accordance with the AAMl Recommended Practice for Reuse of Hemodialyzers when such automation is chosen for use by a prescribing physician. It is also indicated for record keeping of these functions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024076 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024076: Maky 21.1 Dialyzer Reprocessing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024076

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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