510(k) · Cleared
Recalled · Class III · 2022CBC-PLT-4 Whole Blood Control/Multiple
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 Nov 1, 1984 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 1, 1984
- Review
- 21 days
- Class
- Class II
- Product code
- JPK
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK843962 CBC-PLT-4 Whole Blood Control/MultipleR&D Systems, Inc. · 1984
- Descendant · cites it directly · 0 of its ownK073178 HCT Extended Hematology Control, Model HCT004R&D Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK061511 R&D CBC-3D + CRP Hematology ControlR&D Systems, Inc. · 2006
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 |
|---|---|---|---|---|---|
| 0 (this device) | K843962 | CBC-PLT-4 Whole Blood Control/Multiple | R&D Systems, Inc. | 1984 | — |
| +1 | K073178 | HCT Extended Hematology Control, Model HCT004 | R&D Systems, Inc. | 2007 | — |
| +1 | K061511 | R&D CBC-3D + CRP Hematology Control | R&D Systems, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2022 | Class III | Z-0999-2023 | Under Investigation by firm | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination. |
| Sep 14, 2012 | Class III | Z-0429-2013 | Nonconforming Material/Component | HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010. |
| Apr 15, 2004 | Not classified | Z-0992-04 | Other | Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K073178 (R&D Systems, Inc., 2007) 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 | — |
https://510kreport.com/device/K843962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K843962: CBC-PLT-4 Whole Blood Control/Multiple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843962
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026