510(k) · Cleared
ClearedHC WBC Hematology Control, Model: WBC00S
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 20, 2007 as substantially equivalent to K904464 (R&D Systems, Inc., 1990) after a 97-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 20, 2007
- Review
- 97 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904464 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK904464 CBC-Laser (R) Hematology Control/Multiple-ModifiedR&D Systems, Inc. · 1990
- This deviceK072268 HC WBC Hematology Control, Model: WBC00SR&D Systems, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904464 | CBC-Laser (R) Hematology Control/Multiple-Modified | R&D Systems, Inc. | 1990 | — |
| 0 (this device) | K072268 | HC WBC Hematology Control, Model: WBC00S | R&D Systems, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K904464 | CBC-Laser (R) Hematology Control/Multiple-ModifiedSummary page 1…ity Control Mixture Product Code: JPK Device Class: II Panel: Hematology (81) Predicate Device R&D Systems CBC-3K Hematology Control, (K904464) manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413. Description of Device The HC WBC Hematology C… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 other device also cites its predicate K904464.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The HC WBC Hematology Control is designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072268: HC WBC Hematology Control, Model: WBC00S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072268
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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