510(k) · Cleared
ClearedPX Coulter (R) Cell Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Electronics, Inc. · JPK Mixture, Hematology Quality Control
Cleared on Jul 17, 1991 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jul 17, 1991
- Review
- 64 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK912133 PX Coulter (R) Cell ControlCoulter Electronics, Inc. · 1991
- Descendant · cites it directly · 5 of its ownK060464 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K060464Coulter 5C Cell ControlBeckman Coulter, Inc. · 2006 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912133 | PX Coulter (R) Cell Control | Coulter Electronics, Inc. | 1991 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (6)
3 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?
- Of its descendants, K060464 (Beckman Coulter, Inc., 2006) has gone furthest, with 5 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/K912133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912133: PX Coulter (R) 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/K912133
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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