# K970986: Wako Direct Bilirubin V

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: May 7, 1997 after 50 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
Longest line of descent: 1 generation back to K912024 (1991). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912024: Automated Biochemical Analyzer (WAK0-20R & 30R), Wako Chemicals USA, Inc. (1991) Summary page 1.

## Most influential descendants
- K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 (2005), 2 descendants of its own
- K223078: Atellica® CH Diazo Direct Bilirubin (D_DBil) (2023), 0 descendants of its own
- K152343: Direct Bilirubin (2016), 0 descendants of its own
- K981276: N-Assay L D-Bil (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K970986
Methodology: https://510kreport.com/methodology