510(k) · Cleared
ClearedSynchron Systems HDL Cholesterol (HDLD) Reagent
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 Jun 7, 2004 as substantially equivalent to K934045 (Beckman Instruments, Inc., 1993) after a 74-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Jun 7, 2004
- Review
- 74 days
- Class
- Class I
- Product code
- LBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934045 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK934045 Beckman HDL Cholesterol ReagentBeckman Instruments, Inc. · 1993
- This deviceK040767 Synchron Systems HDL Cholesterol (HDLD) ReagentBeckman Coulter, Inc. · 2004
- 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 |
|---|---|---|---|---|---|
| −1 | K934045 | Beckman HDL Cholesterol Reagent | Beckman Instruments, Inc. | 1993 | — |
| 0 (this device) | K040767 | Synchron Systems HDL Cholesterol (HDLD) Reagent | Beckman Coulter, Inc. | 2004 | — |
| +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 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? (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 |
|---|---|---|---|
| * | K934045 | Beckman HDL Cholesterol ReagentSummary page 1…Number SYNCHRON SYNCHRQN Systems Beckman K934045 Systems HDLC Reagent Coulter, Inc. HDILD Reagent 5.0 D… | 1993 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K042195 (Beckman Coulter, Inc., 2004) has gone furthest, with 0 descendants of its own.
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?
SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent, when used in conjunction with SYNCHRON® Systems Lipid Calibrator, is intended for the quantitative determination of HDL cholesterol in the high-density lipoprotein (HDL) fraction of serum or plasma on SYNCHRON Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040767: Synchron Systems HDL Cholesterol (HDLD) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040767
Report an extraction error
Are you the manufacturer?
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