510(k) · Cleared
ClearedXN Check
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · JPK Mixture, Hematology Quality Control
Cleared on Oct 19, 2012 as substantially equivalent to K063218 (Streck, 2006) after a 221-day review. Its family tree reaches back 1 generation to 2006. 3 later devices descend from it.
- Decided
- Oct 19, 2012
- Review
- 221 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063218 (2006). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK063218 E-Check (XE)Streck · 2006
- This deviceK120742 XN CheckStreck · 2012
- Descendant · cites it directly · 2 of its ownK141964 XN CheckStreck · 2014
- Descendant · 2 generations on · 0 of its ownK160590 XN CheckStreck · 2016
- Descendant · 2 generations on · 0 of its ownK160586 XN-L CheckStreck · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063218 | E-Check (XE) | Streck | 2006 | — |
| 0 (this device) | K120742 | XN Check | Streck | 2012 | — |
| +1 | K141964 | XN Check | Streck | 2014 | — |
| +2 | K160590 | XN Check | Streck | 2016 | — |
| +2 | K160586 | XN-L Check | Streck | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K063218 | E-Check (XE)Summary page 1…Assayed Hematology Control Classification Name: Hematology quality control mixture (JPK-864.8625) Predicate Device: e-CHECK (XE) mI-K06321 8 Description: XN CHECKTM is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), st… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141964 | XN Check | 2014 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K141964 (Streck, 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JPK
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JPK
296in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPK
2in 2023
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 CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
RBC(10 6/pL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10 3/pL), PLT-F(10 3/pL), ROW-SD(fL), RDW-CV(%), MPV(fL), WBC(10 3/pL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(10 3/pL), LYMPH#(10 3/pL), MONO# (10/pL), EO#(10 3/pL), BASO#(10 3/pL), IG#(10 3/pL), IPF(%), RET#(10 6/pL), RET%, IRF%, RET-HE(pg), NRBC(10 3/pL), NRBC% (/100 WBC)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120742: XN Check.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120742
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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