510(k) · Cleared
Recalled · Class III · 2012Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIT Calibrator, Secondary
Cleared on Jul 18, 2006 as substantially equivalent to K860021 (E.I. Dupont DE Nemours & Co., Inc., 1986) after a 20-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 18, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K860021 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
- This deviceK061818 Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal -…Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK122323 Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge…Siemens Healthcare Diagnostics · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK121907 Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension…Siemens Healthcare Diagnostics · 2012
Most influential descendants
Showing 2 of 2 · See all- K122323Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista…Siemens Healthcare Diagnostics · 2012 · cites it directly0descendants
- K121907Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline Phosphatase…Siemens Healthcare Diagnostics · 2012 · 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) | K061818 | Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330) | Dade Behring, Inc. | 2006 | — |
| +1 | K122323 | Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension… | Siemens Healthcare Diagnostics | 2012 | 1 |
| +1 | K121907 | Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline… | Siemens Healthcare Diagnostics | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 JIT? 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 |
|---|---|---|---|
| * | K860021 | Dimension (TM) Clinical Chemistry SystemSummary page 2…l Equivalence Information: 1. Predicate Device: Dimension® Enzyme Verifier (DC 19) and VITROS Chemistry Products Calibrator Kit 3. 2. Predicate K Number(s): K860021 for Dimension® clinical chemistry system. For the Ortho-Diagnostics VITROS Calibrator Kit 3, a 510(k) number was not… | 1986 |
| * | — | VITROS Chemistry Products Calibrator Kit 3 Named without a submission 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 10, 2012 | Class III | Z-0988-2013 | Nonconforming Material/Component | Correlation slope bias and accuracy shift |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ALP CAL is an in vitro diagnostic product for the calibration of Alkaline Phosphatase (ALP) method on the Dimension Vista' System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061818: Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061818
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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