510(k) · Cleared

Recalled · Class II · 2025

Cal-Chex, a Hematology Calibrator

K840261510(k) TraditionalCleared Feb 21, 198447-day reviewClass II21 CFR 864.8165Recalls 1

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

Streck Laboratories, Inc. · KRZ Calibrator For Hemoglobin And Hematocrit Measurement

Cleared on Feb 21, 1984 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.

Decided: Feb 21, 1984
Review: 47 days
Class: Class II
Product code: KRZ
Recalls: 1
Predicates: 0

7 later devices descend from it, 2 citing it directly.

This deviceK840261 Cal-Chex, a Hematology CalibratorStreck Laboratories, Inc. · 1984
Descendant · cites it directly · 5 of its ownK083200 X-CALStreck · 2009
Descendant · 2 generations on · 2 of its ownK120745 XN CALStreck · 2012
Descendant · 3 generations on · 1 of its ownK141962 XN CALStreck · 2014
Descendant · 2 generations on · 1 of its ownK120747 XN Cal PFStreck · 2012
Descendant · 4 generations on · 0 of its ownK160585 XN CALStreck · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009high 2 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all

K083200X-CALStreck · 2009 · cites it directly5descendants
K120745XN CALStreck · 2012 · 2 generations on2descendants
K141962XN CALStreck · 2014 · 3 generations on1descendant
K120747XN Cal PFStreck · 2012 · 2 generations on1descendant
K160585XN CALStreck · 2016 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K840261	Cal-Chex, a Hematology Calibrator	Streck Laboratories, Inc.	1984	—
+1	K083200	X-CAL	Streck	2009	—
+2	K120745	XN CAL	Streck	2012	—
+3	K141962	XN CAL	Streck	2014	—
+2	K120747	XN Cal PF	Streck	2012	—
+4	K160585	XN CAL	Streck	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0
2012	2	0
2014	2	0
2016	1	0

FIG. 1 — Lineage of K840261, 1984–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KRZ? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K083200	X-CAL	Streck	2009	5
K111204	Cell-Dyn 22 Plus Calibrator	Streck	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 4, 2025	Class II	Z-2086-2025	Under Investigation by firm	Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K083200 (Streck, 2009) has gone furthest, with 5 descendants of its own.

How does its category compare?

All KRZ devices

KRZ Calibrator For Hemoglobin And Hematocrit Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRZ

FDA has decided no KRZ device since 2007.

Median 510(k) review, days · KRZ

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

Recalls per year · KRZ

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRZ

1in 2022

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code KRZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	2
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	1	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	2
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K840261 · printed Nov 6, 2026

Cite this page

510(k) Report. “K840261: Cal-Chex, a Hematology Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840261

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026