510(k) · Cleared
ClearedCoulter Linearity Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Corp. · JPK Mixture, Hematology Quality Control
Cleared on Feb 8, 1996 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 8, 1996
- Review
- 80 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK955334 Coulter Linearity ControlCoulter Corp. · 1996
- Descendant · cites it directly · 2 of its ownK061064 Coulter Lin-C Linearity Control, Models 7547065, 723503Beckman Coulter, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK081641 Coulter Lin-X Linearity ControlBeckman Coulter, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK100790 Coulter Lin-X Linearity Control, Model A81196Beckman Coulter, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K061064Coulter Lin-C Linearity Control, Models 7547065, 723503Beckman Coulter, Inc. · 2006 · cites it directly2descendants
- K081641Coulter Lin-X Linearity ControlBeckman Coulter, Inc. · 2009 · cites it directly1descendant
- K100790Coulter Lin-X Linearity Control, Model A81196Beckman Coulter, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955334 | Coulter Linearity Control | Coulter Corp. | 1996 | — |
| +1 | K061064 | Coulter Lin-C Linearity Control, Models 7547065, 723503 | Beckman Coulter, Inc. | 2006 | — |
| +1 | K081641 | Coulter Lin-X Linearity Control | Beckman Coulter, Inc. | 2009 | — |
| +2 | K100790 | Coulter Lin-X Linearity Control, Model A81196 | Beckman Coulter, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (3)
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?
- Of its descendants, K061064 (Beckman Coulter, Inc., 2006) has gone furthest, with 2 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/K955334 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955334: Coulter Linearity Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955334
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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