510(k) · Cleared
ClearedBilirubin, Dingle Valve DPD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CIG Diazo Colorimetry, Bilirubin
Cleared on Jan 3, 1979 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Jan 3, 1979
- Review
- 51 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
- Descendant · cites it directly · 12 of its ownK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
- Descendant · 2 generations on · 10 of its ownK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- Descendant · 3 generations on · 6 of its ownK063744 Cobas Integra C 111Rochdiag · 2007
- Descendant · 3 generations on · 1 of its ownK131544 Cobas C Bilirubin Total Gen.3Roche Diagnostics · 2013 · Recalled
- Descendant · 4 generations on · 1 of its ownK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K981632Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998 · cites it directly12descendants
- K063543Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322…Roche Diagnostics Corp. · 2006 · 2 generations on10descendants
- K063744Cobas Integra C 111Rochdiag · 2007 · 3 generations on6descendants
- K131544Cobas C Bilirubin Total Gen.3Roche Diagnostics · 2013 · 3 generations on1descendant
- K122083Elitech Clinical Systems CK Nac SLElitechgroup · 2012 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K781921 | Bilirubin, Dingle Valve DPD | Boehringer Mannheim Corp. | 1979 | — |
| +1 | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | Roche Diagnostics/Boehringer Mannheim GmbH | 1998 | — |
| +2 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| +3 | K063744 | Cobas Integra C 111 | Rochdiag | 2007 | — |
| +3 | K131544 | Cobas C Bilirubin Total Gen.3 | Roche Diagnostics | 2013 | 2 |
| +4 | K122083 | Elitech Clinical Systems CK Nac SL | Elitechgroup | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2026 | 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 CIG? 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 CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | 1998 | 12 |
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, K981632 (Roche Diagnostics/Boehringer Mannheim GmbH, 1998) has gone furthest, with 12 descendants of its own.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 1 | — | 0 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K781921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K781921: Bilirubin, Dingle Valve DPD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781921
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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