510(k) · Cleared

Cleared

XN CAL

K160585510(k) TraditionalCleared Dec 22, 2016296-day reviewClass II21 CFR 864.8150

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

Streck · KRX Calibrator For Cell Indices

Cleared on Dec 22, 2016 as substantially equivalent to K141962 (Streck, 2014) after a 296-day review. Its family tree reaches back 4 generations to 1984.

Decided: Dec 22, 2016
Review: 296 days
Class: Class II
Product code: KRX
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K840261 (1984). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK840261 Cal-Chex, a Hematology CalibratorStreck Laboratories, Inc. · 1984 · Recalled
3 generations backK083200 X-CALStreck · 2009
2 generations backK120745 XN CALStreck · 2012
1 generation backK141962 XN CALStreck · 2014
This deviceK160585 XN CALStreck · 2016

View FIG. 1 as a table

Line of descent and top descendants

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

FIG. 1 — Lineage of K160585, 1984–2016Source: 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 KRX? 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
*	K141962	XN CAL Summary page 4 …on Name: Calibrator for Cell Indices (864.8150) Product Code: KRX Panel: Hematology Predicate Device: XN CAL™ (K141962) Intended Use: XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN- 20, XN-2…	Streck	2014	—

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 32 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
1 of the 4 ancestors has a recall of any class.

How does its category compare?

All KRX devices

KRX Calibrator For Cell Indices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · KRX

1in 2016

2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRX

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

Recalls per year · KRX

No recall names KRX since 2007.

Adverse event reports per year · KRX

1in 2013

2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code KRX, 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	1	—	0
2010	0	—	0
2011	1	—	0
2012	2	—	1
2013	0	—	1
2014	2	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21,

XN-L) analyzers. Assayed parameters include:

WBC (10"3/uL), RBC (10"6/uL), HGB (g/dL), HCT (%), PLT (1073/ uL), and RET (%)

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/K160585 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160585: XN CAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160585

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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