510(k) · Cleared
Recalled · 2010Synchron CX (TM)5 Clinical Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Jun 1, 1988 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 1, 1988
- Review
- 54 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK881495 Synchron CX (TM)5 Clinical AnalyzerBeckman Instruments, Inc. · 1988
- Descendant · cites it directly · 0 of its ownK971505 Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc. · 1997 · Recalled
Most influential descendants
Showing 1 of 1 · See all- 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) | K881495 | Synchron CX (TM)5 Clinical Analyzer | Beckman Instruments, Inc. | 1988 | — |
| +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 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971505 | Synchron Systems Cholesterol (Chol) Reagent | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2010 | Not classified | Z-0127-2012 | Software design | The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971505 (Beckman Instruments, Inc., 1997) has gone furthest, with 0 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/K881495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881495: Synchron CX (TM)5 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/K881495
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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