510(k) · Cleared
Recalled · 2003Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JFL Ph Rate Measurement, Carbon-Dioxide
Cleared on Dec 18, 2001 as substantially equivalent to K965240 (Beckman Instruments, Inc., 1997) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Dec 18, 2001
- Review
- 11 days
- Class
- Class II
- Product code
- JFL
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883181 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
- 1 generation backK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
- This deviceK014034 Modification to Synchron LX Clinical Chemistry Systems (LX20 and…Beckman Coulter, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK040975 Genchem CO2 Acid ReagentGenchem, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040975Genchem CO2 Acid ReagentGenchem, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer Reage | Beckman Instruments, Inc. | 1988 | 2 |
| −1 | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent… | Beckman Instruments, Inc. | 1997 | 12 |
| 0 (this device) | K014034 | Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro) | Beckman Coulter, Inc. | 2001 | — |
| +1 | K040975 | Genchem CO2 Acid Reagent | Genchem, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 JFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFL device
- #1 K191298 i-STAT CHEM8+ cartridge with the i-STAT 1 Systemscore 2.4 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX…Summary page 1…vice The SYNCHRON LX® Systems (ISE Module Chemistries) claim substantial equivalence to the SYNCHRON LX® Systems currently in commercial distribution. FDA 510(k) Numbers K965240 (LX20 System) and K011213 (LX20 PRO System). 5.0 Device Description The SYNCHRON LX® Clinical Systems are manufactured by Beckman… | 1997 |
| * | K011213 | Modification to Synchron LX 20 Clinical Chemistry SystemSummary page 1…ems (ISE Module Chemistries) claim substantial equivalence to the SYNCHRON LX® Systems currently in commercial distribution. FDA 510(k) Numbers K965240 (LX20 System) and K011213 (LX20 PRO System). 5.0 Device Description The SYNCHRON LX® Clinical Systems are manufactured by Beckman Coulter, Inc. The SYNCHRO… | 2001 |
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 |
|---|---|---|---|
| K040975 | Genchem CO2 Acid Reagent | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K040975 (Genchem, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K965240.
How does its category compare?
All JFL devicesJFL Ph Rate Measurement, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFL
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JFL
Too few JFL 510(k)s in any year since 2007 to give a median.
Recalls per year · JFL
No recall names JFL since 2007.
Adverse event reports per year · JFL
2in 2011
MAUDE reports naming product code JFL, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SYNCHRON LX ISE Electrolyte Buffer Reagent, SYNCHRON LX ISE Electrolyte Reference Reagent, and CO2 Alkaline Buffer and Acid Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 3, are intended for quantitative determination of carbon dioxide (CO2) in serum or plasma on SYNCHRON LX Systems. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for…
Read the full statement (215 words)
SYNCHRON LX ISE Electrolyte Buffer Reagent, SYNCHRON LX ISE Electrolyte Reference Reagent, and CO2 Alkaline Buffer and Acid Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 3, are intended for quantitative determination of carbon dioxide (CO2) in serum or plasma on SYNCHRON LX Systems.
SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of calcium (CALC) in serum, plasma or urine on SYNCHRON LX Systems.
SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of chloride (CL) in serum, plasma, urine or cerebrospinal fluid (CSF) on SYNCHRON LX Systems.
SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium (K) in serum, plasma or urine on the SYNCHRON LX System.
SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of sodium (NA) in serum, plasma or urine on the SYNCHRON LX System.
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/K014034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014034: Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014034
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026