510(k) · Cleared
ClearedCoulter 6C Cell Control, Models 628027 & A59925
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 Jan 21, 2009 as substantially equivalent to K912133 (Coulter Electronics, Inc., 1991) and 1 other predicate after a 208-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Jan 21, 2009
- Review
- 208 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912133 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK912133 PX Coulter (R) Cell ControlCoulter Electronics, Inc. · 1991
- 1 generation backK060464 Coulter 5C Cell ControlBeckman Coulter, Inc. · 2006
- This deviceK081822 Coulter 6C Cell Control, Models 628027 & A59925Beckman Coulter, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK181599 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator…Beckman Coulter · 2019
- Descendant · 2 generations on · 1 of its ownK193124 Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK240252 UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH…Beckman Coulter, Inc. · 2024 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K181599Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationBeckman Coulter · 2019 · cites it directly2descendants
- K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter · 2020 · 2 generations on1descendant
- K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912133 | PX Coulter (R) Cell Control | Coulter Electronics, Inc. | 1991 | — |
| −1 | K060464 | Coulter 5C Cell Control | Beckman Coulter, Inc. | 2006 | — |
| 0 (this device) | K081822 | Coulter 6C Cell Control, Models 628027 & A59925 | Beckman Coulter, Inc. | 2009 | — |
| +1 | K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Beckman Coulter | 2019 | — |
| +2 | K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020 | 1 |
| +3 | 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 |
|---|---|---|
| 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? (2)
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…y quality control mixture (21 CFR § 864 8625) 4 Predicate Device: Candidate(s) Predicate Manufacturer Docket Number COULTER® 6C Cell COULTER® 5C® Beckman Coulter, Inc | K912133 Control Cell Control & (Cleared as K060464 COULTER® PX Cell Control) . COULTER® 6C Cell Control Page 16 Traditional 510(k) Notif… | 1991 |
| * | K060464 | Coulter 5C Cell ControlSummary page 1…25) 4 Predicate Device: Candidate(s) Predicate Manufacturer Docket Number COULTER® 6C Cell COULTER® 5C® Beckman Coulter, Inc | K912133 Control Cell Control & (Cleared as K060464 COULTER® PX Cell Control) . COULTER® 6C Cell Control Page 16 Traditional 510(k) Notification . 5 Description:… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | 2019 | 2 |
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181599 (Beckman Coulter, 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K912133.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
6C 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
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K081822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081822: Coulter 6C Cell Control, Models 628027 & A59925.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081822
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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