# K781921: Bilirubin, Dingle Valve DPD

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 3, 1979 after 51 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981632: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent (1998), 12 descendants of its own
- K063543: Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226 (2006), 10 descendants of its own
- K063744: Cobas Integra C 111 (2007), 6 descendants of its own
- K131544: Cobas C Bilirubin Total Gen.3 (2013), 1 descendant of its own
- K122083: Elitech Clinical Systems CK Nac SL (2012), 1 descendant of its own

Source page: https://510kreport.com/device/K781921
Methodology: https://510kreport.com/methodology