510(k) · Cleared
ClearedDimension Vista Total Iron Binding Capacity 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 May 31, 2006 as substantially equivalent to K994114 (Dade Behring, Inc., 2000) after a 27-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- May 31, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863840 (1986). No later device cites it as a predicate yet.
- Root · 2 generations backK863840 Meth. & Cali. for the Dimension Clini/Chem. SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
- 1 generation backK994114 Dimension Total Iron Binding Capacity (Ibct) CalibratorDade Behring, Inc. · 2000
- This deviceK061251 Dimension Vista Total Iron Binding Capacity CalibratorDade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863840 | Meth. & Cali. for the Dimension Clini/Chem. System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | — |
| −1 | K994114 | Dimension Total Iron Binding Capacity (Ibct) Calibrator | Dade Behring, Inc. | 2000 | — |
| 0 (this device) | K061251 | Dimension Vista Total Iron Binding Capacity Calibrator | Dade Behring, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K994114 | Dimension Total Iron Binding Capacity (Ibct) CalibratorSummary page 1…(TIBC) Calibrator FDA Classification Name/Product Code: Calibrator / JIS Predicate Device: Dimension® IBCT Calibrator (K994114) Device Description: The Dimension Vista TM Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin based prod… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K994114.
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 Dimension VistaT M Total Iron Binding Capacity (TIBC) Calibrator is intended for
use in the calibration of the TIBC method on the Dimension VistaT M system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061251: Dimension Vista Total Iron Binding Capacity Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061251
Report an extraction error
Are you the manufacturer?
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