510(k) · Cleared
ClearedN Latex Ferritin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · DBF Ferritin, Antigen, Antiserum, Control
Cleared on Mar 27, 1995 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 27, 1995
- Review
- 40 days
- Class
- Class II
- Product code
- DBF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK950707 N Latex FerritinBehring Diagnostics, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK993273 N Latex FerritinDade Behring, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK963292 Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 0 of its ownK110736 Advia Chemistry Ferritin (FRT) MethodSiemens Healthcare Diagnostics, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK031650 Ferritin Generation 2Roche Diagnostics Corp. · 2003
Most influential descendants
Showing 4 of 4 · See all- K993273N Latex FerritinDade Behring, Inc. · 1999 · cites it directly1descendant
- K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · cites it directly1descendant
- K110736Advia Chemistry Ferritin (FRT) MethodSiemens Healthcare Diagnostics, Inc. · 2011 · 2 generations on0descendants
- K031650Ferritin Generation 2Roche Diagnostics Corp. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950707 | N Latex Ferritin | Behring Diagnostics, Inc. | 1995 | — |
| +1 | K993273 | N Latex Ferritin | Dade Behring, Inc. | 1999 | — |
| +1 | K963292 | Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1996 | 2 |
| +2 | K110736 | Advia Chemistry Ferritin (FRT) Method | Siemens Healthcare Diagnostics, Inc. | 2011 | 3 |
| +2 | K031650 | Ferritin Generation 2 | Roche Diagnostics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K993273 (Dade Behring, Inc., 1999) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K950707 · printed Nov 3, 2026
Cite this page
510(k) Report. “K950707: N Latex Ferritin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K950707
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026