510(k) · Cleared

Cleared

Serim Blood Leak Test Strip

K990206510(k) TraditionalCleared Apr 21, 199990-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. · FJD Detector, Leak, Blood

Cleared on Apr 21, 1999 as substantially equivalent to K896454 (Boehringer Mannheim Corp., 1990) after a 90-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.

Decided: Apr 21, 1999
Review: 90 days
Class: Class II
Product code: FJD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K896454 (1990). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK896454 Chemstrip (R) 10 with SG Urine Test StripsBoehringer Mannheim Corp. · 1990
This deviceK990206 Serim Blood Leak Test StripSerim Research Corp. · 1999
Descendant · cites it directly · 1 of its ownK012115 Serim Blood Leak Test Strip-2Serim Research Corp. · 2001
Descendant · cites it directly · 0 of its ownK042322 Sterichek Blood Leak Reagent StripsHach Company · 2004

Most influential descendants

Showing 2 of 2 · See all

K012115Serim Blood Leak Test Strip-2Serim Research Corp. · 2001 · cites it directly1descendant
K042322Sterichek Blood Leak Reagent StripsHach Company · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K896454	Chemstrip (R) 10 with SG Urine Test Strips	Boehringer Mannheim Corp.	1990	—
0 (this device)	K990206	Serim Blood Leak Test Strip	Serim Research Corp.	1999	—
+1	K012115	Serim Blood Leak Test Strip-2	Serim Research Corp.	2001	—
+1	K042322	Sterichek Blood Leak Reagent Strips	Hach Company	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	1	0

FIG. 1 — Lineage of K990206, 1990–2004Source: 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 FJD? 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
*	K896454	Chemstrip (R) 10 with SG Urine Test Strips Summary page 1 …d function to the occult blood test pad on Chemstrip 10 urine test strip manufactured by Boehringer Mannheim Corporation which was the subject of Premarket Notification #K896454 The product is similar in utility to the cyanomethemoglobin assay. Supportive data for substantial equivalence to the latter was…	Boehringer Mannheim Corp.	1990	—

Also cleared against K896454: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012115	Serim Blood Leak Test Strip-2	Serim Research Corp.	2001	1
K042322	Sterichek Blood Leak Reagent Strips	Hach Company	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, K012115 (Serim Research Corp., 2001) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K896454.

How does its category compare?

All FJD devices

FJD Detector, Leak, Blood: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FJD

1in 2013

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJD

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

Recalls per year · FJD

No recall names FJD since 2007.

Adverse event reports per year · FJD

1in 2025

2007high 1 (2023) · low 0 (2007)2025

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

What is it indicated for?

SERIM Blood Leak Test Strips provide a rapid and convenient

means for testing spent dialysate for blood in hemodialysis

clinics. The presence of blood in dialysate indicates a

leak in the dialysis membrane.

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/K990206 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990206: Serim Blood Leak 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/K990206

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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