510(k) · Cleared
Recalled · Class II · 2020Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791
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 Dec 30, 2005 as substantially equivalent to K970986 (Wako Chemicals USA, Inc., 1997) after a 52-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 30, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- JFM
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912024 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK912024 Automated Biochemical Analyzer (WAK0-20R & 30R)Wako Chemicals USA, Inc. · 1991
- 1 generation backK970986 Wako Direct Bilirubin VWako Chemicals USA, Inc. · 1997
- This deviceK053132 Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691…Wako Chemicals USA, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK223078 Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK152343 Direct BilirubinRandox Laboratories Limited · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912024 | Automated Biochemical Analyzer (WAK0-20R & 30R) | Wako Chemicals USA, Inc. | 1991 | — |
| −1 | K970986 | Wako Direct Bilirubin V | Wako Chemicals USA, Inc. | 1997 | — |
| 0 (this device) | K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 | Wako Chemicals USA, Inc. | 2005 | — |
| +1 | K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +1 | K152343 | Direct Bilirubin | Randox Laboratories Limited | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K970986 | Wako Direct Bilirubin VSummary page 1…ation. 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) # 970986). The previously marketed device (51 Ok# 970986) was marketed for serum samples and this submission adds the use of plasma as a s… | 1997 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2020 | Class II | Z-1536-2020 | Under Investigation by firm | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| Feb 13, 2020 | Class II | Z-1538-2020 | Under Investigation by firm | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223078 (Siemens Healthcare Diagnostics, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K970986.
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 | — |
What is it indicated for?
Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053132
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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