510(k) · Cleared
ClearedTriglycerides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories Limited · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on Aug 6, 2015 as substantially equivalent to K923508 (Randox Laboratories, Ltd., 1993) after a 132-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 6, 2015
- Review
- 132 days
- Class
- Class I
- Product code
- CDT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923508 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK923508 Triglycerides Gpo-PapRandox Laboratories, Ltd. · 1993
- This deviceK150819 TriglyceridesRandox Laboratories Limited · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923508 | Triglycerides Gpo-Pap | Randox Laboratories, Ltd. | 1993 | — |
| 0 (this device) | K150819 | Triglycerides | Randox Laboratories Limited | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K923508 | Triglycerides Gpo-PapSummary page 5…Page 5 === 4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Randox Laboratories Ltd, Triglycerides reagent 510 (k) Number: K923508 5. INTENDED USE For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in t… | 1993 |
| † | K053153 | Randox Calibration Serum | 2006 |
| † | K942458 | Precision-Multi-Sera - Human - Normal and Elevated | 1995 |
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.
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. 2015, this device’s year, is highlighted.
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 in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and
treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction
This in vitro diagnostic device is intended for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150819: Triglycerides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150819
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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