510(k) · Cleared
Recalled · Class II · 2018Triglycerides Gpo Without Free Glycerol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on Aug 28, 1987 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 28, 1987
- Review
- 24 days
- Class
- Class I
- Product code
- CDT
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK873049 Triglycerides Gpo Without Free GlycerolBoehringer Mannheim Corp. · 1987
- Descendant · cites it directly · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
Most influential descendants
Showing 1 of 1 · See all- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873049 | Triglycerides Gpo Without Free Glycerol | Boehringer Mannheim Corp. | 1987 | — |
| +1 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181373 | Extended Lipid Panel Assay | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2018 | Class II | Z-1125-2019 | Device Design | COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over |
| May 7, 2015 | Class II | Z-1930-2015 | Under Investigation by firm | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K181373 (Laboratory Corporation of America Holdings, 2018) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K873049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K873049: Triglycerides Gpo Without Free Glycerol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873049
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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