510(k) · Cleared
ClearedCoulter Lin-X Linearity 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 Jan 16, 2009 as substantially equivalent to K955334 (Coulter Corp., 1996) and 2 other predicates after a 219-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jan 16, 2009
- Review
- 219 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K955334 (1996). 3 ancestors in all, the oldest K942822 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955334 Coulter Linearity ControlCoulter Corp. · 1996
- 1 generation backK061064 Coulter Lin-C Linearity Control, Models 7547065, 723503Beckman Coulter, Inc. · 2006
- This deviceK081641 Coulter Lin-X Linearity ControlBeckman Coulter, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK100790 Coulter Lin-X Linearity Control, Model A81196Beckman Coulter, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K100790Coulter Lin-X Linearity Control, Model A81196Beckman Coulter, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955334 | Coulter Linearity Control | Coulter Corp. | 1996 | — |
| −1 | K061064 | Coulter Lin-C Linearity Control, Models 7547065, 723503 | Beckman Coulter, Inc. | 2006 | — |
| 0 (this device) | K081641 | Coulter Lin-X Linearity Control | Beckman Coulter, Inc. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K955334 | Coulter Linearity ControlSummary page 1…Docket Number COULTER® LIN-X COULTER® LIN-C® Beckman Coulter, Inc K955334 Lineanty Control Lineanty Control and (Cleared as… | 1996 |
| * | K061064 | Coulter Lin-C Linearity Control, Models 7547065, 723503Summary page 1…Inc K955334 Lineanty Control Lineanty Control and (Cleared as K061064 COULTER® Linearity Controls) CBC-… | 2006 |
| * | K942822 | CBC-Line Hematology Linearity ControlSummary page 1…Linearity Controls) CBC-Lme R&D Systems Hematology Lmeanty K942822 Kit (for calibration assessment only) 50 Description… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100790 | Coulter Lin-X Linearity Control, Model A81196 | 2010 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100790 (Beckman Coulter, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K955334.
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?
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 your Product Manuals or On-line Help System
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081641 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081641: Coulter Lin-X 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/K081641
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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