510(k) · Cleared
ClearedCoulter Lin-X Linearity Control, Model A81196
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 Dec 21, 2010 as substantially equivalent to K081641 (Beckman Coulter, Inc., 2009) after a 274-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Dec 21, 2010
- Review
- 274 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955334 (1996). 4 ancestors in all, the oldest K942822 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK955334 Coulter Linearity ControlCoulter Corp. · 1996
- 2 generations backK061064 Coulter Lin-C Linearity Control, Models 7547065, 723503Beckman Coulter, Inc. · 2006
- 1 generation backK081641 Coulter Lin-X Linearity ControlBeckman Coulter, Inc. · 2009
- This deviceK100790 Coulter Lin-X Linearity Control, Model A81196Beckman Coulter, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955334 | Coulter Linearity Control | Coulter Corp. | 1996 | — |
| −2 | K061064 | Coulter Lin-C Linearity Control, Models 7547065, 723503 | Beckman Coulter, Inc. | 2006 | — |
| −1 | K081641 | Coulter Lin-X Linearity Control | Beckman Coulter, Inc. | 2009 | — |
| 0 (this device) | K100790 | Coulter Lin-X Linearity Control, Model A81196 | Beckman Coulter, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K081641 | Coulter Lin-X Linearity ControlSummary page 2…(pending 510(k) clearance K100489). The stability of Level 1-5 and Level 7 was previously cleared in K081641. Value Value assignment of Level 6 WBC for Established process for Assignment… | 2009 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a 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?
COULTER® LIN-X Linearity Controls are intended to assess calibration and verify the reportable range of Coulter® Cellular Analysis Systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to Instructions for Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100790: Coulter Lin-X Linearity Control, Model A81196.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100790
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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