510(k) · Cleared
ClearedVigil PRX Chemistry Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman-Diagnostic Systems Group · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Apr 15, 1994 after a 109-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Apr 15, 1994
- Review
- 109 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK936184 Vigil PRX Chemistry ControlBeckman-Diagnostic Systems Group · 1994
- Descendant · cites it directly · 3 of its ownK974452 Vigil Lipid ControlBeckman Instruments, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 1 of its ownK983640 Synchron Systems Lipid CalibratorBeckman Coulter, Inc. · 1998 · Recalled
- Descendant · 3 generations on · 0 of its ownK042195 Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus…Beckman Coulter, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK020521 Modification to Vigil Lipid ControlBeckman Coulter, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK982224 Vigil Protein ControlBeckman Coulter, Inc. · 1998
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K974452Vigil Lipid ControlBeckman Instruments, Inc. · 1997 · cites it directly3descendants
- K983640Synchron Systems Lipid CalibratorBeckman Coulter, Inc. · 1998 · 2 generations on1descendant
- K042195Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2…Beckman Coulter, Inc. · 2004 · 3 generations on0descendants
- K020521Modification to Vigil Lipid ControlBeckman Coulter, Inc. · 2002 · 2 generations on0descendants
- K982224Vigil Protein ControlBeckman Coulter, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936184 | Vigil PRX Chemistry Control | Beckman-Diagnostic Systems Group | 1994 | — |
| +1 | K974452 | Vigil Lipid Control | Beckman Instruments, Inc. | 1997 | 1 |
| +2 | K983640 | Synchron Systems Lipid Calibrator | Beckman Coulter, Inc. | 1998 | 1 |
| +3 | K042195 | Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus… | Beckman Coulter, Inc. | 2004 | — |
| +2 | K020521 | Modification to Vigil Lipid Control | Beckman Coulter, Inc. | 2002 | — |
| +1 | K982224 | Vigil Protein Control | Beckman Coulter, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
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 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
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? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K974452 (Beckman Instruments, Inc., 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JJY devicesJJY 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 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 | — |
https://510kreport.com/device/K936184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936184: Vigil PRX Chemistry Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936184
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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