510(k) · Cleared

Cleared

Beckman HDL Cholesterol Reagent

K934045510(k) TraditionalCleared Oct 14, 199356-day reviewClass I21 CFR 862.1475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Instruments, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Cleared on Oct 14, 1993 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Oct 14, 1993
Review: 56 days
Class: Class I
Product code: LBS
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK934045 Beckman HDL Cholesterol ReagentBeckman Instruments, Inc. · 1993
Descendant · cites it directly · 1 of its ownK040767 Synchron Systems HDL Cholesterol (HDLD) ReagentBeckman Coulter, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK042195 Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus…Beckman Coulter, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all

K040767Synchron Systems HDL Cholesterol (HDLD) ReagentBeckman Coulter, Inc. · 2004 · cites it directly1descendant
K042195Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2…Beckman Coulter, Inc. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K934045	Beckman HDL Cholesterol Reagent	Beckman Instruments, Inc.	1993	—
+1	K040767	Synchron Systems HDL Cholesterol (HDLD) Reagent	Beckman Coulter, Inc.	2004	—
+2	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	2	0

FIG. 1 — Lineage of K934045, 1993–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040767	Synchron Systems HDL Cholesterol (HDLD) Reagent	Beckman Coulter, Inc.	2004	1

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?

Of its descendants, K040767 (Beckman Coulter, Inc., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LBS devices

LBS 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

2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBS

118in 2011

2007high 129 (2008) · low 118 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LBS

1in 2013

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LBS

6in 2025

2007high 6 (2025) · low 0 (2007)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	—

https://510kreport.com/device/K934045 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934045: Beckman HDL Cholesterol Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934045

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026