510(k) · Cleared
ClearedDma Triglycerides Procedures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Data Medical Associates, Inc. · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on May 29, 1997 after a 63-day review. The FDA summary names no predicate by number.
- Decided
- May 29, 1997
- Review
- 63 days
- Class
- Class I
- Product code
- CDT
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 CDT? 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All CDT devicesCDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · CDT
Too few CDT 510(k)s in any year since 2007 to give a median.
Recalls per year · CDT
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDT
12in 2025
MAUDE reports naming product code CDT, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 11 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 0 | — | 3 | 12 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the quantitative determination of Triglycerides in serum and plasma. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or vatious endocrine disorders. Elevated serum triglyceride levels are seen in primary disorders of lipid f metabolism or hyperlipoproteinemia secondary to known diseases. Furthermore, in conjunction with…
Read the full statement (96 words)
For the quantitative determination of Triglycerides in serum and plasma. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or vatious endocrine disorders. Elevated serum triglyceride levels are seen in primary disorders of lipid f metabolism or hyperlipoproteinemia secondary to known diseases. Furthermore, in conjunction with high-density lipoprotein and total serum cholesterol, a triglyceride determination provides valuable information for the assessment of coronary heart disease risk. The clinical significance and management of hyperlipoproteinemia depends on the triglyceride distribution among the major serum lipoproteins.
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/K971113 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971113: Dma Triglycerides Procedures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971113
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)
- Page last updated Nov 3, 2026