510(k) · Cleared

Cleared

CDS Hematology Calibrator (CDS Cal)

K041130510(k) AbbreviatedCleared Jun 10, 200441-day reviewClass II21 CFR 864.8165

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

Clinical Diagnostic Solutions, Inc. · KRZ Calibrator For Hemoglobin And Hematocrit Measurement

Cleared on Jun 10, 2004 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Jun 10, 2004
Review: 41 days
Class: Class II
Product code: KRZ
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K041130Source: FDA 510(k) database · How lineage is built

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

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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’s file for it is a 510(k) statement, which names no predicate.

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.

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	—

What is it indicated for?

Read the full statement (118 words)

The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that resembles red cells, white cells and platelets in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including Beckman Coulter S Plus IL-VI series, STKR, JS, JR, ST and JT series, STKS, MAXM, HmX, Gen.S, MD series, OnyX, T series and AT and AT diff series analyzers; the Abbott Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 analyzers, intended to count red cells, white cells and platelets. It is a suspension of particles or cells whose size, shape, concentration and other characteristics have been precisely and accurately determined.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K041130 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041130: CDS Hematology Calibrator (CDS Cal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041130

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026