510(k) · Cleared
ClearedDimension Total Iron Binding Capacity (Ibct) 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 Jan 20, 2000 as substantially equivalent to K863840 (E.I. Dupont DE Nemours & Co., Inc., 1986) after a 45-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Jan 20, 2000
- Review
- 45 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863840 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK863840 Meth. & Cali. for the Dimension Clini/Chem. SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
- This deviceK994114 Dimension Total Iron Binding Capacity (Ibct) CalibratorDade Behring, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK061251 Dimension Vista Total Iron Binding Capacity CalibratorDade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK052867 Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 2005 · Recalled
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 |
|---|---|---|---|---|---|
| −1 | K863840 | Meth. & Cali. for the Dimension Clini/Chem. System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | — |
| 0 (this device) | K994114 | Dimension Total Iron Binding Capacity (Ibct) Calibrator | Dade Behring, Inc. | 2000 | — |
| +1 | K061251 | Dimension Vista Total Iron Binding Capacity Calibrator | Dade Behring, Inc. | 2006 | — |
| +1 | K052867 | Vitros Chemistry Products Dtibc Reagent | Ortho-Clinical Diagnostics, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K863840 | Meth. & Cali. for the Dimension Clini/Chem. SystemSummary page 1…ate of Preparation: December 2, 1999 Name of Product: Dimension® IBCT Calibrator FDA Classification Name: Calibrator Predicate Device: Dimension® IRN/TIBC Calibrator, K863840 Device Description: The Dimension® IBCT Calibrator is a liquid protein based product. The kit consists of six vials; two at each… | 1986 |
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)
No FDA recall names this device.
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 IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.
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/K994114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994114: Dimension Total Iron Binding Capacity (Ibct) Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994114
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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