510(k) · Cleared

Cleared

Sterichek Blood Leak Reagent Strips

K042322510(k) TraditionalCleared Dec 7, 2004103-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

Hach Company · FJD Detector, Leak, Blood

Cleared on Dec 7, 2004 as substantially equivalent to K012115 (Serim Research Corp., 2001) and 1 other predicate after a 103-day review. Its family tree reaches back 3 generations to 1990.

Decided: Dec 7, 2004
Review: 103 days
Class: Class II
Product code: FJD
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K896454 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK896454 Chemstrip (R) 10 with SG Urine Test StripsBoehringer Mannheim Corp. · 1990
2 generations backK990206 Serim Blood Leak Test StripSerim Research Corp. · 1999
1 generation backK012115 Serim Blood Leak Test Strip-2Serim Research Corp. · 2001
This deviceK042322 Sterichek Blood Leak Reagent StripsHach Company · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K896454	Chemstrip (R) 10 with SG Urine Test Strips	Boehringer Mannheim Corp.	1990	—
−2	K990206	Serim Blood Leak Test Strip	Serim Research Corp.	1999	—
−1	K012115	Serim Blood Leak Test Strip-2	Serim Research Corp.	2001	—
0 (this device)	K042322	Sterichek Blood Leak Reagent Strips	Hach Company	2004	—

FIG. 1 — Lineage of K042322, 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K012115	Serim Blood Leak Test Strip-2 Summary page 1 …ation Name: 21 CFR 876.5820 Hemodialysis system and accessories, Class II Product Code: 78-FJD Predicate Device: SerimTM Blood Leak Test Strips, 510(k) No. K012115 and K990206 Device Description: The device is made up of a 0.20 inch square yellow reagent pad that has…	Serim Research Corp.	2001	—
*	K990206	Serim Blood Leak Test Strip Summary page 1 …21 CFR 876.5820 Hemodialysis system and accessories, Class II Product Code: 78-FJD Predicate Device: SerimTM Blood Leak Test Strips, 510(k) No. K012115 and K990206 Device Description: The device is made up of a 0.20 inch square yellow reagent pad that has been chemica…	Serim Research Corp.	1999	—

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 14 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
None of the 3 ancestors has a recall.

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?

SteriChek® Blood Leak Reagent Strips provide a quick convenient means of checking the presence of Blood in dialysate to assist in confirming an alarm by the blood leak monitor of the Hemodialysis machine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042322 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042322: Sterichek Blood Leak Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042322

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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