510(k) · Cleared

Recalled · 2004

Vigil Lipid Control

K974452510(k) TraditionalCleared Dec 17, 199722-day reviewClass I21 CFR 862.1660Recalls 1

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

Beckman Instruments, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Dec 17, 1997 as substantially equivalent to K936184 (Beckman-Diagnostic Systems Group, 1994) after a 22-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it. It has been recalled once.

Decided: Dec 17, 1997
Review: 22 days
Class: Class I
Product code: JJY
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K936184 (1994). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK936184 Vigil PRX Chemistry ControlBeckman-Diagnostic Systems Group · 1994
This deviceK974452 Vigil Lipid ControlBeckman Instruments, Inc. · 1997
Descendant · cites it directly · 1 of its ownK983640 Synchron Systems Lipid CalibratorBeckman Coulter, Inc. · 1998 · Recalled
Descendant · 2 generations on · 0 of its ownK042195 Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus…Beckman Coulter, Inc. · 2004
Descendant · cites it directly · 0 of its ownK020521 Modification to Vigil Lipid ControlBeckman Coulter, Inc. · 2002

Most influential descendants

Showing 3 of 3 · See all

K983640Synchron Systems Lipid CalibratorBeckman Coulter, Inc. · 1998 · cites it directly1descendant
K042195Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2…Beckman Coulter, Inc. · 2004 · 2 generations on0descendants
K020521Modification to Vigil Lipid ControlBeckman Coulter, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K936184	Vigil PRX Chemistry Control	Beckman-Diagnostic Systems Group	1994	—
0 (this device)	K974452	Vigil Lipid Control	Beckman Instruments, Inc.	1997	—
+1	K983640	Synchron Systems Lipid Calibrator	Beckman Coulter, Inc.	1998	1
+2	K042195	Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus…	Beckman Coulter, Inc.	2004	—
+1	K020521	Modification to Vigil Lipid Control	Beckman Coulter, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2004	1	0

FIG. 1 — Lineage of K974452, 1994–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJY? 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? (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	Applicant	Decided	Recalls
*	K936184	Vigil PRX Chemistry Control Summary page 1 …945 DEC \| 7 197 Quality Control Material (assayed and unassayed) (21 CFR § 862.1660) Predicate Device(s): VIGIL™ Lipid Controls \| VIGIL PR)('”r Beckman Instruments, \| K936184 Controls Inc. Description: The VIGIL™ Lipid Controls are four level ready-to-use human serum-based liquid controls manufactured…	Beckman-Diagnostic Systems Group	1994	—

Also cleared against K936184: 2 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K983640	Synchron Systems Lipid Calibrator	Beckman Coulter, Inc.	1998	1
K020521	Modification to Vigil Lipid Control	Beckman Coulter, Inc.	2002	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 30, 2004	Not classified	Z-1101-04	Other	Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K983640 (Beckman Coulter, Inc., 1998) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K936184.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

Beckman’s Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol, HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.

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/K974452 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974452: Vigil Lipid Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974452

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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