510(k) · Cleared
ClearedSynchron CX 7 Clinical Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Oct 22, 1990 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 22, 1990
- Review
- 40 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK904219 Synchron CX 7 Clinical AnalyzerBeckman · 1990
- Descendant · cites it directly · 1 of its ownK112377 BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK140690 BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK103531 Prestige 24I; Biolis 24I; MGC 240Tokyo Boeki Medisys, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK971505 Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc. · 1997 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K112377BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · cites it directly1descendant
- K140690BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014 · 2 generations on0descendants
- K103531Prestige 24I; Biolis 24I; MGC 240Tokyo Boeki Medisys, Inc. · 2011 · cites it directly0descendants
- K971505Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904219 | Synchron CX 7 Clinical Analyzer | Beckman | 1990 | — |
| +1 | K112377 | BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +2 | K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
| +1 | K103531 | Prestige 24I; Biolis 24I; MGC 240 | Tokyo Boeki Medisys, Inc. | 2011 | — |
| +1 | K971505 | Synchron Systems Cholesterol (Chol) Reagent | Beckman Instruments, Inc. | 1997 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K112377 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2012) has gone furthest, with 1 descendant 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/K904219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904219: Synchron CX 7 Clinical Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904219
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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