510(k) · Cleared
Recalled · Class III · 2012Dimension Iron Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIS Calibrator, Primary
Cleared on Mar 9, 2006 as substantially equivalent to K944093 (E.I. Dupont DE Nemours & Co., Inc., 1994) after a 36-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 9, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- JIS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944093 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK944093 Dimension (R) XL Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1994
- This deviceK060266 Dimension Iron CalibratorDade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK061793 Dimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K061793Dimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944093 | Dimension (R) XL Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1994 | — |
| 0 (this device) | K060266 | Dimension Iron Calibrator | Dade Behring, Inc. | 2006 | — |
| +1 | K061793 | Dimension Vista Iron Flex Reagent Cartridge and Calibrator | Dade Behring, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 JIS? 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? (1)
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 |
|---|---|---|---|
| * | K944093 | Dimension (R) XL Clinical Chemistry SystemSummary page 2…of 6 ampules, two at each of three levels. Substantial Equivalence Information: 1. Predicate Device: Dimension® IRN/TIBC Calibrator (DC21) 2. Predicate K Number(s): K944093 3. Comparison with Predicate: Similarities Intended Use To calibrate the iron met… | 1994 |
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 |
|---|---|---|---|
| K061793 | Dimension Vista Iron Flex Reagent Cartridge and Calibrator | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2012 | Class III | Z-0745-2013 | Nonconforming Material/Component | Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060266 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060266: Dimension Iron Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060266
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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