510(k) · Cleared
ClearedR&D CBC-XE Hematology Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R&D Systems, Inc. · JPK Mixture, Hematology Quality Control
Cleared on Sep 1, 2004 as substantially equivalent to K913879 (R&D Systems, Inc., 1991) after a 29-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Sep 1, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913879 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913879 CBC-8K (TM) Hematology Control/MultipleR&D Systems, Inc. · 1991
- This deviceK042094 R&D CBC-XE Hematology ControlR&D Systems, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK160606 BC-5D Hematology ControlR&D Systems, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK100050 R & D Systems Xeret Hematology ControlR&D Systems, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913879 | CBC-8K (TM) Hematology Control/Multiple | R&D Systems, Inc. | 1991 | — |
| 0 (this device) | K042094 | R&D CBC-XE Hematology Control | R&D Systems, Inc. | 2004 | — |
| +1 | K160606 | BC-5D Hematology Control | R&D Systems, Inc. | 2016 | — |
| +1 | K100050 | R & D Systems Xeret Hematology Control | R&D Systems, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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 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 |
|---|---|---|---|
| * | K913879 | CBC-8K (TM) Hematology Control/MultipleSummary page 1…rol mixture. Device Class: Class II Predicate Device: R&D Systems CBC-8K Hematology Control, K913879 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413 Description: This control is a hematology contr… | 1991 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K160606 (R&D Systems, Inc., 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.
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?
R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex TM hematology instruments. Refer to assay sheet for specific instrument models.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042094: R&D CBC-XE Hematology Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042094
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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