510(k) · Cleared

Cleared

Coulter Body Fluid Control

K082162510(k) TraditionalCleared Feb 3, 2009187-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 Feb 3, 2009 as substantially equivalent to K912133 (Coulter Electronics, Inc., 1991) and 1 other predicate after a 187-day review. Its family tree reaches back 2 generations to 1991.

Decided: Feb 3, 2009
Review: 187 days
Class: Class II
Product code: JPK
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K912133 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK912133 PX Coulter (R) Cell ControlCoulter Electronics, Inc. · 1991
1 generation backK060464 Coulter 5C Cell ControlBeckman Coulter, Inc. · 2006
This deviceK082162 Coulter Body Fluid ControlBeckman Coulter, Inc. · 2009

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)	K082162	Coulter Body Fluid Control	Beckman Coulter, Inc.	2009	—

FIG. 1 — Lineage of K082162, 1991–2009Source: 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? (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	Applicant	Decided	Recalls
*	K912133	PX Coulter (R) Cell Control Summary page 1 …Number COULTER® Body COULTER® 5C® Beckman Coulter, Inc. K912133 Fluid Control Cell Control & (Cl…	Coulter Electronics, Inc.	1991	—
*	K060464	Coulter 5C Cell Control Summary page 1 …Fluid Control Cell Control & (Cleared as K060464 COULTER® PX Cell Control) COULTER® Body Fluid Con…	Beckman Coulter, Inc.	2006	—

Also cleared against K912133: 2 other devices →

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 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.
2 other devices also cite its predicate K912133.

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. 2009, this device’s year, is highlighted.

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?

Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System. Refer to the System HELP or Instructions for Use.

The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range. This product can also be used to establish your own laboratory mean.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082162 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082162: Coulter Body Fluid Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082162

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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