510(k) · Cleared

Recalled · Class II · 2014

Dimension Vista Cyclosporine (Csa) Flex Reagent Cartridge

K062236510(k) SpecialCleared Aug 21, 200619-day reviewClass II21 CFR 862.1235Recalls 2

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

Cleared on Aug 21, 2006 as substantially equivalent to K023065 (Dade Behring, Inc., 2002) after a 19-day review. Its family tree reaches back 2 generations to 1989. It has been recalled 2 times.

Decided: Aug 21, 2006
Review: 19 days
Class: Class II
Product code: MKW
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to P890025 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backP890025 TD Cyclosporine and Metabolites Serum AssayAbbott Laboratories · 1989 · Recalled
1 generation backK023065 Cyclosporine (Csa) Flex Reagent CartridgeDade Behring, Inc. · 2002
This deviceK062236 Dimension Vista Cyclosporine (Csa) Flex Reagent CartridgeDade Behring, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	P890025	TD Cyclosporine and Metabolites Serum Assay	Abbott Laboratories	1989	1
−1	K023065	Cyclosporine (Csa) Flex Reagent Cartridge	Dade Behring, Inc.	2002	—
0 (this device)	K062236	Dimension Vista Cyclosporine (Csa) Flex Reagent Cartridge	Dade Behring, Inc.	2006	—

FIG. 1 — Lineage of K062236, 1989–2006Source: 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 MKW? 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
*	K023065	Cyclosporine (Csa) Flex Reagent Cartridge Summary page 1 …e: 862.1235 Cyclosporine Cyclosporine test system Product code: MKW Predicate Device: Dimension® Cyclosporine (CSA) Flex® reagent cartridge (K023065) Device Description: Dade Behring Dimension VistaTM Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (as…	Dade Behring, Inc.	2002	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 19, 2014	Class II	Z-1647-2014	Device Design	A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled…
Dec 5, 2013	Class II	Z-0818-2014	Nonconforming Material/Component	Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All MKW devices

MKW Cyclosporine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKW

3in 2008

2007high 3 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKW

177in 2008

2007high 177 (2008)2026

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

Recalls per year · MKW

1in 2013

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · MKW

8in 2025

2007high 108 (2011) · low 0 (2007)2025

MAUDE reports naming product code MKW, 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	0	—	0	0
2008	3	177	0	0
2009	0	—	0	0
2010	0	—	1	2
2011	0	—	1	108
2012	0	—	0	36
2013	0	—	1	30
2014	0	—	0	4
2015	0	—	0	2
2016	0	—	0	4
2017	0	—	0	0
2018	0	—	0	3
2019	0	—	0	4
2020	0	—	0	2
2021	0	—	0	6
2022	0	—	0	7
2023	0	—	0	5
2024	0	—	0	6
2025	0	—	0	8
2026	0	—	0	—

What is it indicated for?

The Dimension VistaTM Cyclosporine (CSA) Flex® reagent cartridge is an in vitro

device intended to quantitatively determine cyclosporine concentrations in human whole

blood. Measurements of CSA are used as an aid in the management of heart, liver, and

kidney transplant patients receiving therapy with this drug.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062236 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062236: Dimension Vista Cyclosporine (Csa) Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062236

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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