510(k) · Cleared
Recalled · 2009Dimension Vista Chemistry 3 Calibrator, Model KC130
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Sep 22, 2006 after a 43-day review. The FDA summary names no predicate by number. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 22, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK062334 Dimension Vista Chemistry 3 Calibrator, Model KC130Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK123677 Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3…Siemens Healthcare Diagnostics · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK123321 Dimension Chemistry Iii CalibratorySiemens Healthcare Diagnostics · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062334 | Dimension Vista Chemistry 3 Calibrator, Model KC130 | Dade Behring, Inc. | 2006 | — |
| +1 | K123677 | Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator… | Siemens Healthcare Diagnostics | 2013 | 1 |
| +1 | K123321 | Dimension Chemistry Iii Calibratory | Siemens Healthcare Diagnostics | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 JIX? 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?
The FDA summary names no predicate by number.
What descends from it? (2)
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 |
|---|---|---|---|---|
| Oct 23, 2009 | Not classified | Z-1535-2010 | Other | patient results are depressed |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123677 (Siemens Healthcare Diagnostics, 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC), ammonia (AMON) and carbon dioxide (CO2) methods on the Dimension Vista TM System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062334: Dimension Vista Chemistry 3 Calibrator, Model KC130.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062334
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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