510(k) · Cleared
Recalled · 2003Synchron Systems Lipid Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JIS Calibrator, Primary
Cleared on Dec 21, 1998 as substantially equivalent to K974452 (Beckman Instruments, Inc., 1997) after a 66-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 21, 1998
- Review
- 66 days
- Class
- Class II
- Product code
- JIS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936184 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK936184 Vigil PRX Chemistry ControlBeckman-Diagnostic Systems Group · 1994
- 1 generation backK974452 Vigil Lipid ControlBeckman Instruments, Inc. · 1997 · Recalled
- This deviceK983640 Synchron Systems Lipid CalibratorBeckman Coulter, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK042195 Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus…Beckman Coulter, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042195Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2…Beckman Coulter, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936184 | Vigil PRX Chemistry Control | Beckman-Diagnostic Systems Group | 1994 | — |
| −1 | K974452 | Vigil Lipid Control | Beckman Instruments, Inc. | 1997 | 1 |
| 0 (this device) | K983640 | Synchron Systems Lipid Calibrator | Beckman Coulter, Inc. | 1998 | — |
| +1 | K042195 | Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus… | Beckman Coulter, Inc. | 2004 | — |
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 JIS? 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? (1)
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 |
|---|---|---|---|
| * | K974452 | Vigil Lipid ControlSummary page 1…Device(s): SYNCHRON Systems Predicate . Reagent Manufacturer ’ Number SYNCHRON® Systems Beck ~VIGIL Linid Lipid Calibrator C?Jcr;ltrrglan ipi Beckman Coulter, Inc. K974452 Description: . The SYNCHRON Systems Lipid Calibrator Set is a two level ready-to-use human serum- based liquid calibrator set… | 1997 |
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 |
|---|---|---|---|
| K042195 | Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2… | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2003 | Not classified | Z-1153-04 | Other | Incorrect units are printed in labeling but not in software. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K042195 (Beckman Coulter, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K974452.
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SYNCHRON® Systems Lipid Calibrator, used in conjunction with SYNCHRON® HDL Cholesterol reagent, is intended for use on Beckman’s SYNCHRON Systems for the calibration of HDL Cholesterol test systems.
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/K983640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983640: Synchron Systems Lipid Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983640
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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