510(k) · Cleared
Recalled · Class II · 2011Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L
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 Mar 10, 1997 as substantially equivalent to K950958 (Beckman Instruments, Inc., 1995) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1988. 17 later devices descend from it. It has been recalled 12 times.
- Decided
- Mar 10, 1997
- Review
- 70 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 12
- Predicates
- 5
Its longest line of descent runs back 1 generation to K883181 (1988). 3 ancestors in all. 17 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
- This deviceK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997
- Descendant · cites it directly · 11 of its ownK042291 Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 5 of its ownK183688 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK183678 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK191298 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK210958 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K042291Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004 · cites it directly11descendants
- K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 2 generations on5descendants
- K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 2 generations on4descendants
- K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 2 generations on4descendants
- K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer Reage | Beckman Instruments, Inc. | 1988 | 2 |
| 0 (this device) | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent… | Beckman Instruments, Inc. | 1997 | — |
| +1 | K042291 | Unicel DXC 600 and 800 Synchron Systems | Beckman Coulter, Inc. | 2004 | 34 |
| +2 | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +2 | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +2 | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +3 | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950958 | Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta)Summary page 2…ystems K9509858 LX20 Albumin Assay SYNCHRON 8ystems Albumin K883181 LX20 Creatinine Assay SYNCHRON Systems Creatinine K850958 LX20 Glucose Assay SYNCHRON Systems Glucose K950958 LX20 Phosphorus Assay SYNCHRON 8ystems Phosphorus K883181 LX20 Total Protein Assay SYNCHRON Systems Total Protein K950958 LX20 Ur… | 1995 |
| * | K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer ReageSummary page 2…ystems Summary of Safety & Effectiveness 40 5.0 6.0 Predicate Device(s) SYNCHRON LX20 System SYNCHRON CX Systems K9509858 LX20 Albumin Assay SYNCHRON 8ystems Albumin K883181 LX20 Creatinine Assay SYNCHRON Systems Creatinine K850958 LX20 Glucose Assay SYNCHRON Systems Glucose K950958 LX20 Phosphorus Ass… | 1988 |
| Kept off the family tree | K850958 | FDA’s K850958 is Blood Gas Sampler Kit Our OCR of the scanned summary read K850958, FDA’s number for Blood Gas Sampler Kit (Churchill Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SYNCHRON Systems Creatinine”. Kept off the family tree. Summary page 2…edicate Device(s) SYNCHRON LX20 System SYNCHRON CX Systems K9509858 LX20 Albumin Assay SYNCHRON 8ystems Albumin K883181 LX20 Creatinine Assay SYNCHRON Systems Creatinine K850958 LX20 Glucose Assay SYNCHRON Systems Glucose K950958 LX20 Phosphorus Assay SYNCHRON 8ystems Phosphorus K883181 LX20 Total Protein… | 1985 |
| * | K942676 | Synchron CX3 DeltaSummary page 2…ioride K850958 LX20 Potassium Assay SYNCHRON Systems Potassium K9850958 LX20 Sodium Assay SYNCHRON Systems Sodium K9850958 LX AQUA CAL 1,2,3 SYNCHRON 8ystems Aqueous Cal K942676 SYNCHRON Protein Cal SYNCHRON Systems Protein Cal K952676 Description The LX20 Clinical Chemistry System is a fully automated,… | 1994 |
| Kept off the family tree | K952676 | FDA’s K952676 is Branemark System Ball Attachment System Our OCR of the scanned summary read K952676, FDA’s number for Branemark System Ball Attachment System (Nobelpharma USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SYNCHRON Systems Protein Cal”. Kept off the family tree. Summary page 2…sium K9850958 LX20 Sodium Assay SYNCHRON Systems Sodium K9850958 LX AQUA CAL 1,2,3 SYNCHRON 8ystems Aqueous Cal K942676 SYNCHRON Protein Cal SYNCHRON Systems Protein Cal K952676 Description The LX20 Clinical Chemistry System is a fully automated, computer controlied, clinical chemistry analyzer intended… | 1995 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042291 | Unicel DXC 600 and 800 Synchron Systems | 2004 | 11 |
| K014034 | Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro) | 2001 | 1 |
| K071277 | Synchron LX20 Clinical Systems, Creatinine Test Systems | 2007 | 0 |
| K971505 | Synchron Systems Cholesterol (Chol) Reagent | 1997 | 0 |
| K970905 | Synchron CX Systems Lipase (Lipa) Reagent | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2011 | Not classified | Z-2130-2011 | Equipment maintenance | The recall was initiated because Beckman Coulter has received reports of incorrect electrolyte results on Synchron LX systems due to a variety of maintenance-related hardware issues. |
| Oct 22, 2010 | Not classified | Z-2071-2011 | Environmental control | This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified. |
| Sep 22, 2010 | Class II | Z-1951-2013 | Process control | Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments. |
| Aug 10, 2010 | Not classified | Z-1619-2011 | Other | The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples drawn by lancets are more likely to be… |
| Aug 2, 2010 | Not classified | Z-2389-2010 | Pending | The recall was initiated after Beckman Coulter confirmed reports that black / brown particulates were observed in some bottles of the Creatinine Alkaline Buffer (Buffer lot M911427 and M911518) in modular Creatinine (CREm) reagent kit… |
| Apr 15, 2010 | Not classified | Z-2388-2010 | Other | UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment. |
| Apr 5, 2007 | Not classified | Z-1094-2008 | Software design | Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags… |
| Sep 6, 2005 | Not classified | Z-0009-06 | Software design | Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results… |
| Oct 10, 2003 | Not classified | Z-1098-04 | Other | Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly. |
| Oct 7, 2003 | Not classified | Z-1116-04 | Other | 'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual. |
| Sep 18, 2003 | Not classified | Z-0096-04 | Other | Sample wheel may home to the wrong position. |
| Dec 16, 2002 | Not classified | Z-0545-03 | Other | The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The SYNCHRON LX20 Clinical Chemistry System is a fully automated, computer controlled, clinical chemistry analyzer intended for the in vitro quantitative measurement of a variety of analytes of clinical interest in biological fluids, such as, serum, plasma, urine, and cerebral spinal fluid (sample type is chemistry dependent).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965240 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965240
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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