510(k) · Cleared
ClearedBoehringer Mannheim Igg Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Cleared on Feb 9, 1996 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Feb 9, 1996
- Review
- 42 days
- Class
- Class II
- Product code
- DFZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK955906 Boehringer Mannheim Igg AssayBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 0 of its ownK040434 Roche Diagnostics Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2004
- Descendant · cites it directly · 0 of its ownK982382 Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1998 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K955906 | Boehringer Mannheim Igg Assay | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K040434 | Roche Diagnostics Tina-Quant Igg Gen.2 | Roche Diagnostics Corp. | 2004 | — |
| +1 | K982382 | Cobas Integra Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 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 DFZ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K040434 (Roche Diagnostics Corp., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DFZ devicesDFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DFZ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · DFZ
Too few DFZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DFZ
No recall names DFZ since 2007.
Adverse event reports per year · DFZ
No MAUDE report names DFZ 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 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 | — |
https://510kreport.com/device/K955906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955906: Boehringer Mannheim Igg Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955906
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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