510(k) · Cleared
ClearedOlympus Ferritin Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · DBF Ferritin, Antigen, Antiserum, Control
Cleared on Feb 6, 2003 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 6, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- DBF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK030124 Olympus Ferritin ReagentOlympus America, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK062746 Ferritin-Latex, Models 1418-2070, 1418-0279Medicon Hellas S.A · 2006
Most influential descendants
Showing 1 of 1 · See all- K062746Ferritin-Latex, Models 1418-2070, 1418-0279Medicon Hellas S.A · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030124 | Olympus Ferritin Reagent | Olympus America, Inc. | 2003 | — |
| +1 | K062746 | Ferritin-Latex, Models 1418-2070, 1418-0279 | Medicon Hellas S.A | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DBF device
- #1 K193650 LIAISON Ferritinscore 2.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K062746 | Ferritin-Latex, Models 1418-2070, 1418-0279 | 2006 | 0 |
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?
- Of its descendants, K062746 (Medicon Hellas S.A, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DBF devicesDBF Ferritin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DBF
Too few DBF 510(k)s in any year since 2007 to give a median.
Recalls per year · DBF
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DBF
1in 2025
MAUDE reports naming product code DBF, 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 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reagent for the determination of ferritin concentrations in human serum using the Olympus family of clinical chemistry analyzers.
Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bone-marrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030124: Olympus Ferritin Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030124
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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