510(k) · Cleared
ClearedDimension Vista Csae Flex Regent Cartridge, Model K4108
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · MKW Cyclosporine
Cleared on Aug 5, 2008 as substantially equivalent to K052017 (Dade Behring, Inc., 2005) after a 22-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Aug 5, 2008
- Review
- 22 days
- Class
- Class II
- Product code
- MKW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P890025 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backP890025 TD Cyclosporine and Metabolites Serum AssayAbbott Laboratories · 1989 · Recalled
- 1 generation backK052017 Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge…Dade Behring, Inc. · 2005
- This deviceK081992 Dimension Vista Csae Flex Regent Cartridge, Model K4108Siemens Healthcare Diagnostics, Inc. · 2008
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 | K052017 | Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108 | Dade Behring, Inc. | 2005 | — |
| 0 (this device) | K081992 | Dimension Vista Csae Flex Regent Cartridge, Model K4108 | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
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
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 |
|---|---|---|---|
| * | K052017 | Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108Summary page 1…imension Vista® CSAE Flex® reagent cartridge / Cyclosporine test system 3. Identification of the Predicate Device Dimension® CSAE Flex® reagent cartridge, K052017 4. Device Description The Dimension Vista® CSAE Flex® reagent cartridge is a pre-packaged in-vitro diagno… | 2005 |
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 19 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All MKW devicesMKW Cyclosporine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MKW
3in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MKW
177in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKW
8in 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 CSAE method is an in vitro diagnostic test for the quantitative measurement of
cyclosporine A (CSA) in human whole blood on the Dimension Vista® system.
Measurements of CSA are used as an aid in the management of heart, liver and kidney
transplant patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081992: Dimension Vista Csae Flex Regent Cartridge, Model K4108.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081992
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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