510(k) · Cleared

Cleared

Serim Dialysate Monitor Test Strip

K043031510(k) TraditionalCleared Jun 13, 2005222-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

Serim Research Corp. · NTZ Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

Cleared on Jun 13, 2005 as substantially equivalent to K945491 (Serim Research Corp., 1995) and 2 other predicates after a 222-day review. Its family tree reaches back 2 generations to 1999.

Decided: Jun 13, 2005
Review: 222 days
Class: Class II
Product code: NTZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K992431 (1999). 4 ancestors in all, the oldest K945491 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK992431 Neo-2 MeterAutomata Instrumentation, Inc. · 1999
1 generation backK020908 HDM97Ibp Instruments GmbH · 2002
This deviceK043031 Serim Dialysate Monitor Test StripSerim Research Corp. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K992431	Neo-2 Meter	Automata Instrumentation, Inc.	1999	—
−1	K020908	HDM97	Ibp Instruments GmbH	2002	—
0 (this device)	K043031	Serim Dialysate Monitor Test Strip	Serim Research Corp.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1999	1	0

FIG. 1 — Lineage of K043031, 1999–2005Source: 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 NTZ? 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? (3)

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
*	K945491	Serim (TM) Bicarb PH Reagent Strips Summary page 2 …Dialysate Legally marketed device MonitorM Test Pad Test for pH in dialysate K945491 Previously cleared - no significant modifications whic…	Serim Research Corp.	1995	—
*	K992257	New Multiples Reagent Strips Summary page 2 …indications for use. Test for glucose as tracer Bayer Multistix® 1OSG (glucose for acid concentrate in pad) K992257 dialysate Test for bicarbonate in IBP Gmbh Model HDM97…	Bayer Corp.	1999	—
*	K020908	HDM97 Summary page 2 …IBP Gmbh Model HDM97 dialysate conductivity meter 510(k) number K020908 Device Description: SERIM Dialysate Monitor Test Strips are firm plastic strips that contain three…	Ibp Instruments GmbH	2002	—

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 6 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
None of the 4 ancestors has a recall.

How does its category compare?

All NTZ devices

NTZ Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NTZ

FDA has decided no NTZ device since 2007.

Median 510(k) review, days · NTZ

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

Recalls per year · NTZ

No recall names NTZ since 2007.

Adverse event reports per year · NTZ

No MAUDE report names NTZ since 2007.

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	—	0
2026	—	—

What is it indicated for?

The Serim Tm Dialysate MonitorTM Test Strip provides semi-quantitative indications of

pH, bicarbonate, and glucose (which acts as a tracer for the acid concentrate)

concentrations in final bicarbonate dialysate solutions. They can be used to monitor

the proper preparation of such dialysate solutions. The SerimTm Dialysate Monitor MT

Test Strips are to be used to supplement current methods for testing dialysate.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043031 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043031: Serim Dialysate Monitor Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043031

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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