510(k) · Cleared
ClearedX-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 Feb 3, 2009 as substantially equivalent to K840261 (Streck Laboratories, Inc., 1984) after a 96-day review. Its family tree reaches back 1 generation to 1984. 5 later devices descend from it.
- Decided
- Feb 3, 2009
- Review
- 96 days
- Class
- Class II
- Product code
- KRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K840261 (1984). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK840261 Cal-Chex, a Hematology CalibratorStreck Laboratories, Inc. · 1984 · Recalled
- This deviceK083200 X-CALStreck · 2009
- Descendant · cites it directly · 2 of its ownK120745 XN CALStreck · 2012
- Descendant · 2 generations on · 1 of its ownK141962 XN CALStreck · 2014
- Descendant · cites it directly · 1 of its ownK120747 XN Cal PFStreck · 2012
- Descendant · 3 generations on · 0 of its ownK160585 XN CALStreck · 2016
- Descendant · 2 generations on · 0 of its ownK141955 XN Cal PFStreck · 2014
Most influential descendants
Showing 5 of 5 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840261 | Cal-Chex, a Hematology Calibrator | Streck Laboratories, Inc. | 1984 | 1 |
| 0 (this device) | K083200 | X-CAL | Streck | 2009 | — |
| +1 | K120745 | XN CAL | Streck | 2012 | — |
| +2 | K141962 | XN CAL | Streck | 2014 | — |
| +1 | K120747 | XN Cal PF | Streck | 2012 | — |
| +3 | K160585 | XN CAL | Streck | 2016 | — |
| +2 | K141955 | XN Cal PF | Streck | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K840261 | Cal-Chex, a Hematology CalibratorSummary page 1…gy calibrator Classification Names: Calibrator for Cell Indices (864.8150) Classification Numbers: KRX Predicate Devices: Cal-Chex- K840261 Description: X-Cal is a stabilized suspension of human and animal blood, in a solution containing biological salts and anti-micr… | 1984 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All KRX devicesKRX Calibrator For Cell Indices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
X-Cal is used to calibrate and verify calibration of Sysmex hematology analyzers.
Refer to product assay sheet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083200: X-CAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083200
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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