510(k) · Cleared
ClearedSynchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Sep 16, 2004 as substantially equivalent to K040767 (Beckman Coulter, Inc., 2004) and 1 other predicate after a 34-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 16, 2004
- Review
- 34 days
- Class
- Class I
- Product code
- LBS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K936184 (1994). 5 ancestors in all, the oldest K934045 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK936184 Vigil PRX Chemistry ControlBeckman-Diagnostic Systems Group · 1994
- 2 generations backK974452 Vigil Lipid ControlBeckman Instruments, Inc. · 1997 · Recalled
- 1 generation backK983640 Synchron Systems Lipid CalibratorBeckman Coulter, Inc. · 1998 · Recalled
- This deviceK042195 Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus…Beckman Coulter, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936184 | Vigil PRX Chemistry Control | Beckman-Diagnostic Systems Group | 1994 | — |
| −2 | K974452 | Vigil Lipid Control | Beckman Instruments, Inc. | 1997 | 1 |
| −1 | K983640 | Synchron Systems Lipid Calibrator | Beckman Coulter, Inc. | 1998 | 1 |
| 0 (this device) | K042195 | Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus… | Beckman Coulter, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 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 LBS? 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? (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 |
|---|---|---|---|
| * | K040767 | Synchron Systems HDL Cholesterol (HDLD) ReagentSummary page 1…I ~~ ~ ~ ~ ~ ~Number SYNCHRON SYNCHRON Beckman K(040767 Systems Systems Coulter, Inc. HDIL Reagent HOILD R… | 2004 |
| * | K983640 | Synchron Systems Lipid CalibratorSummary page 1…ystems Coulter, Inc. HDIL Reagent HOILD Reagent Beckman K983640 SYNCHRON® SYNCHRON® Coulter, Inc. Systems Lipid Plus Systems… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All LBS devicesLBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBS
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · LBS
118in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBS
6in 2025
MAUDE reports naming product code LBS, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 129 | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 3 | 118 | 0 | 3 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma. HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the…
Read the full statement (110 words)
HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
The SYNCHRON® Systems Lipid Plus Calibrator 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042195: Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042195
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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