510(k) · Cleared
ClearedXN Check BF
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 Dec 5, 2014 as substantially equivalent to K120744 (Streck, 2012) after a 140-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Dec 5, 2014
- Review
- 140 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000076 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000076 Cell-ChexStreck Laboratories, Inc. · 2000
- 3 generations backK051706 IQ Body Fluids ControlStreck · 2005
- 2 generations backK053362 Cell-Chex AutoStreck · 2006
- 1 generation backK120744 XN Check BFStreck · 2012
- This deviceK141957 XN Check BFStreck · 2014
- Descendant · cites it directly · 0 of its ownK160588 XN Check BFStreck · 2016
Most influential descendants
Showing 1 of 1 · See all- K160588XN Check BFStreck · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000076 | Cell-Chex | Streck Laboratories, Inc. | 2000 | — |
| −3 | K051706 | IQ Body Fluids Control | Streck | 2005 | — |
| −2 | K053362 | Cell-Chex Auto | Streck | 2006 | — |
| −1 | K120744 | XN Check BF | Streck | 2012 | — |
| 0 (this device) | K141957 | XN Check BF | Streck | 2014 | — |
| +1 | K160588 | XN Check BF | Streck | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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 |
|---|---|---|---|
| * | K120744 | XN Check BFSummary page 4…Hematology quality control mixture (864.8625) Product Code: JPK Panel: Hematology Predicate Device: XN CHECK™ BF (K120744) Intended Use: XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20 XN-21)… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160588 | XN Check BF | 2016 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K160588 (Streck, 2016) has gone furthest, with 0 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. 2014, 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 BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
WBC-BF (1073/ul), RBC-BF (1076/ ul), MN# (1073/ul), PMN# (1073/ul), MN% (%), PMN% (%), TC-BF# (1073/pul)
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/K141957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141957: XN Check BF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141957
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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