510(k) · Cleared

Cleared

Conductivity Standard Solution-Metercare

K032075510(k) TraditionalCleared Sep 17, 200372-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

Ibp Instruments GmbH · FKH Solution-Test Standard-Conductivity, Dialysis

Cleared on Sep 17, 2003 as substantially equivalent to K851362 (Rna Medical Corp., 1985) after a 72-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Sep 17, 2003
Review: 72 days
Class: Class II
Product code: FKH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K851362 (1985). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK851362 Standard Solution of Conductivity & Measurement ofRna Medical Corp. · 1985
This deviceK032075 Conductivity Standard Solution-MetercareIbp Instruments GmbH · 2003
Descendant · cites it directly · 0 of its ownK041636 H&S-Conductivity Standard SolutionH & S Technical Services · 2004 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K041636H&S-Conductivity Standard SolutionH & S Technical Services · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K032075, 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

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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
*	K851362	Standard Solution of Conductivity & Measurement of Summary page 1 …oduct Code: FKH Panel: Advisory Committee Gastroenterology 5 . Predicate Device: STANDARD SOLUTION OF KNOWN CONDUCTIVITY 510(k) Number: K851362 RNA MEDICAL CORP 2 1 CUMMINGS PARK SUITE 228 WOBURN, MA 01801 510(k) Su…	Rna Medical Corp.	1985	—

Also cleared against K851362: 1 other device →

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
K041636	H&S-Conductivity Standard Solution	H & S Technical Services	2004	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, K041636 (H & S Technical Services, 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K851362.

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?

The "Conductivity Standard Solution - MeterCare" may be used to calibrate conductivity reference meters used to test the dialysate, dialysate concentrate and water treatment systems used with dialysate delivering systems.

Metercare is an Over-the-counter product and needs no prescription. The product is for In Vitro use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032075 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032075: Conductivity Standard Solution-Metercare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032075

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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