510(k) · Cleared
Recalled · Class II · 2015Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · KHS Enzymatic, Carbon-Dioxide
Cleared on May 25, 2006 as substantially equivalent to K010206 (Dade Behring, Inc., 2001) and 2 other predicates after a 22-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- May 25, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- KHS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K860021 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
- This deviceK061238 Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase…Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK133728 Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133728Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860021 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | 1 |
| 0 (this device) | K061238 | Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex… | Dade Behring, Inc. | 2006 | — |
| +1 | K133728 | Dimension Vista Creatinine (CRE2) Flex Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 KHS? 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? (3)
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 |
|---|---|---|---|
| * | K010206 | Dimension Enzymatic Carbonate (ECO2) Flex Method, Catalog DF137Summary page 1…class Code Dimension Vista TM Dimension® ECO2 C02 Flex® reagent Flex® reagent K010206 II 862.1160 KHS cartridge cartridge Dimension Vista"" Dimension® CREA CREA Flex® reagent… | 2001 |
| * | K925668 | Creatinine Meth for Use on the Dimension Clin ChemSummary page 1…K010206 II 862.1160 KHS cartridge cartridge Dimension Vista"" Dimension® CREA CREA Flex® reagent Flex® reagent K925668 II 862.1125 CGX cartridge cartridge Dimension Vista TM Dimension® LDH LDH Flex® reagent F… | 1992 |
| * | K860021 | Dimension (TM) Clinical Chemistry SystemSummary page 1…K925668 II 862.1125 CGX cartridge cartridge Dimension Vista TM Dimension® LDH LDH Flex® reagent Flex® reagent K860021 II 862.1440* CFJ cartridge cartridge I * Not exempt from premarket notification per 862.… | 1986 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133728 | Dimension Vista Creatinine (CRE2) Flex Reagent Cartridge | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2015 | Class II | Z-2741-2015 | Device Design | Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K133728 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KHS devicesKHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · KHS
143in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHS
40in 2025
MAUDE reports naming product code KHS, 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 | 2 |
| 2009 | 1 | — | 0 | 14 |
| 2010 | 3 | 143 | 0 | 0 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 1 | 35 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 1 | 25 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dimension VistaTM Carbon Dioxide (CO2) Flex® reagent cartridge is a device intended to measure carbon dioxide in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge is a device intended to measure creatinine levels in serum, plasma and urine. Creatinine…
Read the full statement (156 words)
The Dimension VistaTM Carbon Dioxide (CO2) Flex® reagent cartridge is a device intended to measure carbon dioxide in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge is a device intended to measure creatinine levels in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The Dimension VistaTM Lactate dehydrogenase (LDH) Flex® reagent cartridge is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum and plasma. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061238 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061238: Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase 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/K061238
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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