510(k) · Cleared

Cleared

Minncare HD

K133724510(k) TraditionalCleared Aug 27, 2014264-day reviewClass II21 CFR 876.5665

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

Medivators, Inc. · NIH Disinfectant, Subsystem, Water Purification

Cleared on Aug 27, 2014 as substantially equivalent to K023064 (Krd Co., Ltd., 2004) after a 264-day review. Its family tree reaches back 2 generations to 1987.

Decided: Aug 27, 2014
Review: 264 days
Class: Class II
Product code: NIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K861730 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK861730 Actril for Kidney Machine DisinfectantRenal Systems, Inc. · 1987
1 generation backK023064 HemocleanKrd Co., Ltd. · 2004
This deviceK133724 Minncare HDMedivators, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

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

FIG. 1 — Lineage of K133724, 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 NIH? 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
*	K023064	Hemoclean Summary page 5 …Minncare HD is substantially equivalent in formulation, performance and indications to its predicate device - Hemoclean Disinfectant which is cleared under 510k - K023064. Hemoclean is a peracetic acid based liquid chemical germicide disinfectant solutions with similar chemistry, intended use and…	Krd Co., Ltd.	2004	—

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?

The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All NIH devices

NIH Disinfectant, Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NIH

1in 2014

2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NIH

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

Recalls per year · NIH

No recall names NIH since 2007.

Adverse event reports per year · NIH

1in 2025

2007high 7 (2024) · low 0 (2007)2025

MAUDE reports naming product code NIH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	2
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	2
2023	0	—	0
2024	0	—	7
2025	0	—	1
2026	0	—	—

What is it indicated for?

Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20oC.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133724 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133724: Minncare HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133724

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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