510(k) · Cleared

Cleared

Hemoclean

K023064510(k) TraditionalCleared Apr 6, 2004568-day reviewClass II21 CFR 876.5860

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

Krd Co., Ltd. · NII Disinfectant, Dialysate Delivery System

Cleared on Apr 6, 2004 as substantially equivalent to K861730 (Renal Systems, Inc., 1987) after a 568-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided: Apr 6, 2004
Review: 568 days
Class: Class II
Product code: NII
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K861730 (1987). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK861730 Actril for Kidney Machine DisinfectantRenal Systems, Inc. · 1987
This deviceK023064 HemocleanKrd Co., Ltd. · 2004
Descendant · cites it directly · 0 of its ownK133724 Minncare HDMedivators, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all

K133724Minncare HDMedivators, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K861730	Actril for Kidney Machine Disinfectant	Renal Systems, Inc.	1987	—
0 (this device)	K023064	Hemoclean	Krd Co., Ltd.	2004	—
+1	K133724	Minncare HD	Medivators, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K023064, 1987–2014Source: 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 NII? 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
*	K861730	Actril for Kidney Machine Disinfectant Summary page 1 …Accessory for Hemodialysis PREDICATE DEVICE: Minntech/Renal Systems Actril® (510(k) Number: K861730) Device Description: HEMOCLEAN® is a single component germicide that does not require mixing or activation. HEMOCLEAN® is a sta…	Renal Systems, Inc.	1987	—

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
K133724	Minncare HD	Medivators, Inc.	2014	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, K133724 (Medivators, Inc., 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NII devices

NII Disinfectant, Dialysate Delivery System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NII

FDA has decided no NII device since 2007.

Median 510(k) review, days · NII

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

Recalls per year · NII

No recall names NII since 2007.

Adverse event reports per year · NII

1in 2025

2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code NII, 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	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	1
2026	—	—

What is it indicated for?

HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis

machines). It should be used under the following the dilution rate and contact condition:

Hemodialysis Machine Dilution rate Contact time

COBE CentrySystem 3 1:9 10 minutes.

Nikkiso DBB 22B 1:34 29 minutes.

Fresenius 2008K 1:34 15 minutes.

Gambro Phoenix 1:25 15 minutes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023064 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023064: Hemoclean.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023064

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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