510(k) · Cleared
Recalled · Class II · 2015Boehringer Mannheim Cholesterol Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Jul 20, 1995 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 20, 1995
- Review
- 73 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK952127 Boehringer Mannheim Cholesterol AssayBoehringer Mannheim Corp. · 1995
- Descendant · cites it directly · 4 of its ownK031824 Cobas Integra Cholesterol Gen. 2Roche Diagnostics Corp. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
- Descendant · 2 generations on · 0 of its ownK132031 Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014
- Descendant · 2 generations on · 0 of its ownK130200 Piccolo Total Cholesterol - Capillary Test SystemAbaxis, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK111753 Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol…Hitachi Chemical Diagnostics, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K031824Cobas Integra Cholesterol Gen. 2Roche Diagnostics Corp. · 2003 · cites it directly4descendants
- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · 2 generations on0descendants
- K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014 · 2 generations on0descendants
- K130200Piccolo Total Cholesterol - Capillary Test SystemAbaxis, Inc. · 2013 · 2 generations on0descendants
- K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952127 | Boehringer Mannheim Cholesterol Assay | Boehringer Mannheim Corp. | 1995 | — |
| +1 | K031824 | Cobas Integra Cholesterol Gen. 2 | Roche Diagnostics Corp. | 2003 | 1 |
| +2 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
| +2 | K132031 | Afinion Lipid Panel and Afinion Lipid Panel Control | Axis-Shield Poc AS | 2014 | — |
| +2 | K130200 | Piccolo Total Cholesterol - Capillary Test System | Abaxis, Inc. | 2013 | — |
| +2 | K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL… | Hitachi Chemical Diagnostics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031824 | Cobas Integra Cholesterol Gen. 2 | 2003 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2015 | Class II | Z-1920-2015 | 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, K031824 (Roche Diagnostics Corp., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K952127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952127: Boehringer Mannheim Cholesterol Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952127
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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