510(k) · Cleared
ClearedWako Direct Bilirubin V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wako Chemicals USA, Inc. · CIG Diazo Colorimetry, Bilirubin
Cleared on May 7, 1997 as substantially equivalent to K912024 (Wako Chemicals USA, Inc., 1991) after a 50-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- May 7, 1997
- Review
- 50 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912024 (1991). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912024 Automated Biochemical Analyzer (WAK0-20R & 30R)Wako Chemicals USA, Inc. · 1991
- This deviceK970986 Wako Direct Bilirubin VWako Chemicals USA, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK053132 Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691…Wako Chemicals USA, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK223078 Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK152343 Direct BilirubinRandox Laboratories Limited · 2016
- Descendant · cites it directly · 0 of its ownK981276 N-Assay L D-BilCrestat Diagnostics, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K053132Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc. · 2005 · cites it directly2descendants
- K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K152343Direct BilirubinRandox Laboratories Limited · 2016 · 2 generations on0descendants
- K981276N-Assay L D-BilCrestat Diagnostics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912024 | Automated Biochemical Analyzer (WAK0-20R & 30R) | Wako Chemicals USA, Inc. | 1991 | — |
| 0 (this device) | K970986 | Wako Direct Bilirubin V | Wako Chemicals USA, Inc. | 1997 | — |
| +1 | K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 | Wako Chemicals USA, Inc. | 2005 | 2 |
| +2 | K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +2 | K152343 | Direct Bilirubin | Randox Laboratories Limited | 2016 | — |
| +1 | K981276 | N-Assay L D-Bil | Crestat Diagnostics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912024 | Automated Biochemical Analyzer (WAK0-20R & 30R)Summary page 1…idation. The safety and effectiveness of the Wako Direct Bilirubin V assay is demonstrated by its substantial equivalency to our previous Direct Bilirubin assay (510(k)#K912024/A). Both test systems are used to measure total bilirubin is serum. In comparison studies against the predicate assay, a correlat… | 1991 |
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?
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/K970986 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970986: Wako Direct Bilirubin V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970986
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026