510(k) · Cleared
ClearedVigil TDM Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DIF Drug Mixture Control Materials
Cleared on Aug 13, 1997 as substantially equivalent to K936184 (Beckman-Diagnostic Systems Group, 1994) after a 15-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 13, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936184 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK936184 Vigil PRX Chemistry ControlBeckman-Diagnostic Systems Group · 1994
- This deviceK972819 Vigil TDM ControlsBeckman Instruments, Inc. · 1997
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) | K972819 | Vigil TDM Controls | Beckman Instruments, Inc. | 1997 | — |
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 DIF? 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 |
|---|---|---|---|
| * | K936184 | Vigil PRX Chemistry Control | 1994 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K936184.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Beckman Vigil Therapeutic Drug Monitoring (TDM) Controls are designed for monitoring the reliability and overall performance of Beckman Therapeutic Drug test systems in the clinical laboratory. The use of three levels of control allows the laboratorian to monitor change in calibration 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/K972819 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972819: Vigil TDM Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972819
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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