510(k) · Cleared
ClearedAutomated Biochemical Analyzer (WAK0-20R & 30R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wako Chemicals USA, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Jul 19, 1991 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jul 19, 1991
- Review
- 77 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK912024 Automated Biochemical Analyzer (WAK0-20R & 30R)Wako Chemicals USA, Inc. · 1991
- Descendant · cites it directly · 4 of its ownK970986 Wako Direct Bilirubin VWako Chemicals USA, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK970985 Wako Total Bilirubin VWako Chemicals USA, Inc. · 1997
- Descendant · 2 generations on · 2 of its ownK053132 Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691…Wako Chemicals USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK223078 Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK152343 Direct BilirubinRandox Laboratories Limited · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K970986Wako Direct Bilirubin VWako Chemicals USA, Inc. · 1997 · cites it directly4descendants
- K970985Wako Total Bilirubin VWako Chemicals USA, Inc. · 1997 · cites it directly3descendants
- K053132Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc. · 2005 · 2 generations on2descendants
- K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023 · 3 generations on0descendants
- K152343Direct BilirubinRandox Laboratories Limited · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912024 | Automated Biochemical Analyzer (WAK0-20R & 30R) | Wako Chemicals USA, Inc. | 1991 | — |
| +1 | K970986 | Wako Direct Bilirubin V | Wako Chemicals USA, Inc. | 1997 | — |
| +1 | K970985 | Wako Total Bilirubin V | Wako Chemicals USA, Inc. | 1997 | — |
| +2 | K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 | Wako Chemicals USA, Inc. | 2005 | 2 |
| +3 | K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +3 | K152343 | Direct Bilirubin | Randox Laboratories Limited | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2005 | 2 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJE? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
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?
- Of its descendants, K970986 (Wako Chemicals USA, Inc., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | 0 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
https://510kreport.com/device/K912024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912024: Automated Biochemical Analyzer (WAK0-20R & 30R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912024
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026