510(k) · Cleared
ClearedXN CAL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · KRX Calibrator For Cell Indices
Cleared on Dec 5, 2014 as substantially equivalent to K120745 (Streck, 2012) after a 140-day review. Its family tree reaches back 3 generations to 1984. 1 later device descends from it.
- Decided
- Dec 5, 2014
- Review
- 140 days
- Class
- Class II
- Product code
- KRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K840261 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK840261 Cal-Chex, a Hematology CalibratorStreck Laboratories, Inc. · 1984 · Recalled
- 2 generations backK083200 X-CALStreck · 2009
- 1 generation backK120745 XN CALStreck · 2012
- This deviceK141962 XN CALStreck · 2014
- Descendant · cites it directly · 0 of its ownK160585 XN CALStreck · 2016
Most influential descendants
Showing 1 of 1 · See all- K160585XN CALStreck · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K840261 | Cal-Chex, a Hematology Calibrator | Streck Laboratories, Inc. | 1984 | 1 |
| −2 | K083200 | X-CAL | Streck | 2009 | — |
| −1 | K120745 | XN CAL | Streck | 2012 | — |
| 0 (this device) | K141962 | XN CAL | Streck | 2014 | — |
| +1 | K160585 | XN CAL | 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 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
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 |
|---|---|---|---|
| * | K120745 | XN CALSummary page 4…on Name: Calibrator for Cell Indices (864.8150) Product Code: KRX Panel: Hematology Predicate Device: XN CAL™ (K120745) Intended Use: XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-… | 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 |
|---|---|---|---|
| K160585 | XN CAL | 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 30 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K160585 (Streck, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KRX devicesKRX Calibrator For Cell Indices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KRX
1in 2016
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 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) analyzers. Assayed parameters include:
WBC (1073/uL), RBC (1076/pL), HGB (g/dL), HCT (%), PLT (10"3/ puL), 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/K141962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141962: XN CAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141962
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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