510(k) · Cleared

Cleared

Coulter Lin-C Linearity Control, Models 7547065, 723503

K061064510(k) TraditionalCleared May 17, 200630-day reviewClass II21 CFR 864.8625

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Coulter, Inc. · JPK Mixture, Hematology Quality Control

Cleared on May 17, 2006 as substantially equivalent to K955334 (Coulter Corp., 1996) after a 30-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.

Decided: May 17, 2006
Review: 30 days
Class: Class II
Product code: JPK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955334 (1996). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK955334 Coulter Linearity ControlCoulter Corp. · 1996
This deviceK061064 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 2 of 2 · See all

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
−1	K955334	Coulter Linearity Control	Coulter Corp.	1996	—
0 (this device)	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
2009	1	0
2010	1	0

FIG. 1 — Lineage of K061064, 1996–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K955334	Coulter Linearity Control Summary page 1 …Nmbe COULTER® LIN-C® COULTER® UIN-C® Beckman Coulter, Inc. K955334 Linearity Control Linearity Control (Cleared as COULTER®…	Coulter Corp.	1996	—

Also cleared against K955334: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081641	Coulter Lin-X Linearity Control	Beckman Coulter, Inc.	2009	1

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?

Its one ancestor has no recall.
Of its descendants, K081641 (Beckman Coulter, Inc., 2009) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K955334.

How does its category compare?

All JPK devices

JPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPK

4in 2016

2007high 5 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPK

296in 2016

2007high 296 (2016) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JPK

1in 2022

2007high 3 (2011) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JPK

2in 2023

2007high 56 (2011) · low 0 (2009)2025

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-C linearity controls are intended to verify the reportable range of COULTER hematology analyzers 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/K061064 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061064: Coulter Lin-C Linearity Control, Models 7547065, 723503.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061064

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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