510(k) · Cleared
ClearedCoulter 5C 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 Mar 28, 2006 as substantially equivalent to K912133 (Coulter Electronics, Inc., 1991) after a 34-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Mar 28, 2006
- Review
- 34 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912133 (1991). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912133 PX Coulter (R) Cell ControlCoulter Electronics, Inc. · 1991
- This deviceK060464 Coulter 5C Cell ControlBeckman Coulter, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK081822 Coulter 6C Cell Control, Models 628027 & A59925Beckman Coulter, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK181599 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator…Beckman Coulter · 2019
- Descendant · 3 generations on · 1 of its ownK193124 Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter · 2020 · Recalled
- Descendant · 4 generations on · 0 of its ownK240252 UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH…Beckman Coulter, Inc. · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK082162 Coulter Body Fluid ControlBeckman Coulter, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K081822Coulter 6C Cell Control, Models 628027 & A59925Beckman Coulter, Inc. · 2009 · cites it directly3descendants
- K181599Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationBeckman Coulter · 2019 · 2 generations on2descendants
- K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter · 2020 · 3 generations on1descendant
- K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc. · 2024 · 4 generations on0descendants
- K082162Coulter Body Fluid ControlBeckman Coulter, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912133 | PX Coulter (R) Cell Control | Coulter Electronics, Inc. | 1991 | — |
| 0 (this device) | K060464 | Coulter 5C Cell Control | Beckman Coulter, Inc. | 2006 | — |
| +1 | K081822 | Coulter 6C Cell Control, Models 628027 & A59925 | Beckman Coulter, Inc. | 2009 | — |
| +2 | K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Beckman Coulter | 2019 | — |
| +3 | K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020 | 1 |
| +4 | K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer… | Beckman Coulter, Inc. | 2024 | 2 |
| +1 | K082162 | Coulter Body Fluid Control | Beckman Coulter, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K912133 | PX Coulter (R) Cell ControlSummary page 1…Number COULTER-® 5C® Cell COULTER® 5C® Cell Beckman Coulter, Inc. K912133 Control Control (Cleared as COULTER® PX… | 1991 |
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 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?
5C 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 Product Manuals or On-Line Help System.)
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/K060464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060464: Coulter 5C 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/K060464
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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