510(k) · Cleared

Cleared

XN-L Check

K160586510(k) TraditionalCleared Dec 22, 2016296-day reviewClass II21 CFR 864.8625

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

Streck · JPK Mixture, Hematology Quality Control

Cleared on Dec 22, 2016 as substantially equivalent to K141964 (Streck, 2014) after a 296-day review. Its family tree reaches back 3 generations to 2006.

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

Its longest line of descent runs back 3 generations to K063218 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK063218 E-Check (XE)Streck · 2006
2 generations backK120742 XN CheckStreck · 2012
1 generation backK141964 XN CheckStreck · 2014
This deviceK160586 XN-L CheckStreck · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K063218	E-Check (XE)	Streck	2006	—
−2	K120742	XN Check	Streck	2012	—
−1	K141964	XN Check	Streck	2014	—
0 (this device)	K160586	XN-L Check	Streck	2016	—

FIG. 1 — Lineage of K160586, 2006–2016Source: 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 JPK? 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
*	K141964	XN Check Summary page 4 …Hematology quality control mixture (864.8625) Product Code: JPK Panel: Hematology Predicate Device: XN CHECK™ (K141964) Intended Use: XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, in…	Streck	2014	—

Also cleared against K141964: 1 other device →

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 10 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K141964.

How does its category compare?

All JPK devices

JPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · JPK

4in 2016

2007high 5 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPK

296in 2016

2007high 296 (2016) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JPK

1in 2022

2007high 3 (2011) · low 0 (2008)2026

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

Adverse event reports per year · JPK

2in 2023

2007high 56 (2011) · low 0 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	44	1	14
2008	0	—	0	1
2009	5	187	0	0
2010	4	267	2	5
2011	1	—	3	56
2012	2	—	1	2
2013	1	—	0	0
2014	2	—	0	1
2015	0	—	0	0
2016	4	296	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	1
2020	0	—	1	1
2021	0	—	2	1
2022	0	—	1	0
2023	0	—	0	2
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer.

Assayed parameters include:

RBC (1076/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (1073/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (1073/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), 1G (%), NEUT# (10"3/pL), LYMPH# (1073/uL), MONO# (10"3/uL), EO# (1073/uL), BASO# (1073/uL), IG# (10"3/pL), RET# (1076/uL), RET%. IRF%, RET-He (pg).

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/K160586 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160586: XN-L Check.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160586

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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