510(k) · Cleared
ClearedCoulter 4C-EX 300 Cell Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JPK Mixture, Hematology Quality Control
Cleared on Nov 18, 2010 as substantially equivalent to K010064 (Beckman Coulter, Inc., 2001) after a 260-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 18, 2010
- Review
- 260 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010064 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010064 4C-ES Cell, Models 7547187, 7547188, 7547189, 7547190Beckman Coulter, Inc. · 2001
- This deviceK100607 Coulter 4C-EX 300 Cell ControlBeckman Coulter, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010064 | 4C-ES Cell, Models 7547187, 7547188, 7547189, 7547190 | Beckman Coulter, Inc. | 2001 | — |
| 0 (this device) | K100607 | Coulter 4C-EX 300 Cell Control | Beckman Coulter, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K010064 | 4C-ES Cell, Models 7547187, 7547188, 7547189, 7547190Summary page 1…Number COULTER® 4C®~-EX 300 COULTER®4CO-ES Beckman Coulter, K010064 Cell Control Cell Control Inc. (with additional parameter, ROW-SD)… | 2001 |
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.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
4C®-EX 300 Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your instrument specific instructions for use).
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100607: Coulter 4C-EX 300 Cell Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100607
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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