510(k) · Cleared
Recalled · Class II · 2013Dimension Vista Lithium Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · NDW Assay, Porphyrin, Spectrophotometry, Lithium
Cleared on Nov 4, 2011 as substantially equivalent to K011033 (Dade Behring, Inc., 2001) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.
- Decided
- Nov 4, 2011
- Review
- 101 days
- Class
- Class II
- Product code
- NDW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011033 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK011033 Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132Dade Behring, Inc. · 2001
- This deviceK112142 Dimension Vista Lithium Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011033 | Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132 | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K112142 | Dimension Vista Lithium Flex Reagent Cartridge | Siemens Healthcare Diagnostics | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 NDW? 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? (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 | Decided |
|---|---|---|---|
| * | K011033 | Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132Summary page 2…te substantial equivalence to the Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge is the Dimension® Lithium (LI) Flex® Reagent Cartridge previously cleared under K01 1033. The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Drug 4 Calibrator is the current comme… | 2001 |
| * | K011035 | Dimension Drug Calibrator, Model DC22B | 2001 |
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 |
|---|---|---|---|---|
| Feb 21, 2013 | Class II | Z-1151-2013 | Process control | Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K011033.
How does its category compare?
All NDW devicesNDW Assay, Porphyrin, Spectrophotometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NDW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDW
Too few NDW 510(k)s in any year since 2007 to give a median.
Recalls per year · NDW
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDW
2in 2025
MAUDE reports naming product code NDW, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LITH method is an in vitro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
The Drug 4 Calibrator is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112142: Dimension Vista Lithium Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112142
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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