510(k) · Cleared
ClearedWako Total Bilirubin V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wako Chemicals USA, Inc. · JFM Enzymatic Method, Bilirubin
Cleared on Apr 21, 1997 as substantially equivalent to K912024 (Wako Chemicals USA, Inc., 1991) after a 34-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Apr 21, 1997
- Review
- 34 days
- Class
- Class II
- Product code
- JFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912024 (1991). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK912024 Automated Biochemical Analyzer (WAK0-20R & 30R)Wako Chemicals USA, Inc. · 1991
- This deviceK970985 Wako Total Bilirubin VWako Chemicals USA, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK053131 Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801…Wako Chemicals USA, Inc. · 2005 · Recalled
- Descendant · cites it directly · 0 of its ownK981943 DBILAbbott Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK981289 N-Assay L T-BilCrestat Diagnostics, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See allView 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) | K970985 | Wako Total Bilirubin V | Wako Chemicals USA, Inc. | 1997 | — |
| +1 | K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191 | Wako Chemicals USA, Inc. | 2005 | 1 |
| +1 | K981943 | DBIL | Abbott Laboratories | 1998 | — |
| +1 | K981289 | N-Assay L T-Bil | Crestat Diagnostics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2005 | 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 JFM? 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? (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…adate oxidation. The safety and effectiveness of the Wako Bilirubin V assay is demonstrated by its substantial equivalency to our previous Total 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? (3)
3 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 JFM devicesJFM Enzymatic Method, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFM
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JFM
Too few JFM 510(k)s in any year since 2007 to give a median.
Recalls per year · JFM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFM
1in 2025
MAUDE reports naming product code JFM, 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 | 8 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970985 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970985: Wako Total Bilirubin V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970985
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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