510(k) · Cleared

Recalled · Class II · 2025

H&S-Conductivity Standard Solution

K041636510(k) TraditionalCleared Jul 2, 200415-day reviewClass II21 CFR 876.5820Recalls 1

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

H & S Technical Services · FKH Solution-Test Standard-Conductivity, Dialysis

Cleared on Jul 2, 2004 as substantially equivalent to K032075 (Ibp Instruments GmbH, 2003) after a 15-day review. Its family tree reaches back 2 generations to 1985. It has been recalled once.

Decided: Jul 2, 2004
Review: 15 days
Class: Class II
Product code: FKH
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K851362 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK851362 Standard Solution of Conductivity & Measurement ofRna Medical Corp. · 1985
1 generation backK032075 Conductivity Standard Solution-MetercareIbp Instruments GmbH · 2003
This deviceK041636 H&S-Conductivity Standard SolutionH & S Technical Services · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K851362	Standard Solution of Conductivity & Measurement of	Rna Medical Corp.	1985	—
−1	K032075	Conductivity Standard Solution-Metercare	Ibp Instruments GmbH	2003	—
0 (this device)	K041636	H&S-Conductivity Standard Solution	H & S Technical Services	2004	—

FIG. 1 — Lineage of K041636, 1985–2004Source: 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 FKH? 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

Get a 510(k) Report

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K032075	Conductivity Standard Solution-Metercare Our OCR of the scanned summary read K032073, FDA’s number for Gore Introducer Sheath with Silicone Pinch Valve (W. L. Gore & Associates, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Conductivity Standard Solution - MeterCare”.	Ibp Instruments GmbH	2003	—
Kept off the family tree	K043330	FDA’s K043330 is Polypropilene Surgical Sutures Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Demetech Corp.	2005	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 12, 2025	Class II	Z-1185-2026	Under Investigation by firm	due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 18.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All FKH devices

FKH Solution-Test Standard-Conductivity, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKH

1in 2019

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FKH

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

Recalls per year · FKH

No recall names FKH since 2007.

Adverse event reports per year · FKH

2in 2013

2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code FKH, 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	1	—	2
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

"H&S - Conductivity Standard Solutions" are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters; which may include meters and cells used by the hemodialysis technician to verify or calibrate conductivity functions of dialysis related equipment.

These solutions are used remotely from the hemodialysis machine or water purification equipment and do not come in contact with the patient.

Conductivity Standard Solution is for In-Vitro Use Only.

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/K041636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041636: H&S-Conductivity Standard Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041636

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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