510(k) · Cleared

Cleared

Actril for Kidney Machine Disinfectant

K861730510(k) TraditionalCleared Jun 9, 1987399-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

Renal Systems, Inc. · FKQ System, Dialysate Delivery, Central Multiple Patient

Cleared on Jun 9, 1987 after a 399-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jun 9, 1987
Review: 399 days
Class: Class II
Product code: FKQ
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK861730 Actril for Kidney Machine DisinfectantRenal Systems, Inc. · 1987
Descendant · cites it directly · 1 of its ownK023064 HemocleanKrd Co., Ltd. · 2004
Descendant · 2 generations on · 0 of its ownK133724 Minncare HDMedivators, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all

K023064HemocleanKrd Co., Ltd. · 2004 · cites it directly1descendant
K133724Minncare HDMedivators, Inc. · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K861730	Actril for Kidney Machine Disinfectant	Renal Systems, Inc.	1987	—
+1	K023064	Hemoclean	Krd Co., Ltd.	2004	—
+2	K133724	Minncare HD	Medivators, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2014	1	0

FIG. 1 — Lineage of K861730, 1987–2014Source: 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 FKQ? 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? (2)

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

Number	Device	Applicant	Decided	Descendants
K023064	Hemoclean	Krd Co., Ltd.	2004	1

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, K023064 (Krd Co., Ltd., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FKQ devices

FKQ System, Dialysate Delivery, Central Multiple Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKQ

FDA has decided no FKQ device since 2007.

Median 510(k) review, days · FKQ

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

Recalls per year · FKQ

No recall names FKQ since 2007.

Adverse event reports per year · FKQ

6in 2024

2007high 6 (2024) · low 0 (2007)2025

MAUDE reports naming product code FKQ, 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	—	1
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	1
2020	—	0
2021	—	2
2022	—	0
2023	—	3
2024	—	6
2025	—	0
2026	—	—

https://510kreport.com/device/K861730 · printed Nov 6, 2026

Cite this page

510(k) Report. “K861730: Actril for Kidney Machine Disinfectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861730

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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