510(k) · Cleared
Recalled · Class II · 2015Creatinine Meth for Use on the Dimension Clin Chem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.I. Dupont DE Nemours & Co., Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Dec 28, 1992 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 28, 1992
- Review
- 48 days
- Class
- Class II
- Product code
- CGX
- Recalls
- 3
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK925668 Creatinine Meth for Use on the Dimension Clin ChemE.I. Dupont DE Nemours & Co., Inc. · 1992
- Descendant · cites it directly · 1 of its ownK061238 Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase…Dade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK132638 Dimension Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK133728 Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K061238Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent…Dade Behring, Inc. · 2006 · cites it directly1descendant
- K132638Dimension Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants
- K133728Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925668 | Creatinine Meth for Use on the Dimension Clin Chem | E.I. Dupont DE Nemours & Co., Inc. | 1992 | — |
| +1 | K061238 | Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex… | Dade Behring, Inc. | 2006 | 1 |
| +1 | K132638 | Dimension Creatinine (CRE2) Flex Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. | 2014 | 1 |
| +2 | K133728 | Dimension Vista Creatinine (CRE2) Flex Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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… |
| Nov 22, 2011 | Not classified | Z-0772-2012 | Under Investigation by firm | Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent cartridge lots GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237 when processing tests from a well that has been punctured. |
| Dec 27, 2010 | Not classified | Z-1729-2011 | Material/Component Contamination | Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may affect creatinine results for quality… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061238 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K925668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925668: Creatinine Meth for Use on the Dimension Clin Chem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925668
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026