510(k) · Cleared
ClearedCeruloplasmin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter Ireland, Inc. · DDB Ceruloplasmin, Antigen, Antiserum, Control
Cleared on Jan 9, 2017 as substantially equivalent to K053074 (Dade Behring, Inc., 2006) after a 222-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Jan 9, 2017
- Review
- 222 days
- Class
- Class II
- Product code
- DDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K860894 (1986). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 DDB? 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 |
|---|---|---|---|
| * | K053074 | N Antisera to Human CeruloplasminSummary page 4…Docket Number N Antisera to Human Siemens (formerly Ceruloplasmin K053074 Ceruloplasmin Dade-Behring) The Ceruloplasmin reagent is substantially equiva… | 2006 |
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 31 years and passes through 3 companies; a new generation was cleared every 19.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K053074.
How does its category compare?
All DDB devicesDDB Ceruloplasmin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DDB
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DDB
Too few DDB 510(k)s in any year since 2007 to give a median.
Recalls per year · DDB
No recall names DDB since 2007.
Adverse event reports per year · DDB
No MAUDE report names DDB since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161508: Ceruloplasmin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161508
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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