510(k) · Cleared
ClearedLipids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truvian Health · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Dec 30, 2025 as substantially equivalent to K023642 (Abaxis, Inc., 2003) and 1 other predicate after a 264-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Dec 30, 2025
- Review
- 264 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K802743 (1980). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802743 | Ames Sera-Pak Cholesterol Reagent Kit | Miles Laboratories, Inc. | 1980 | — |
| −1 | K023642 | Piccolo Total Cholesterol Test System | Abaxis, Inc. | 2003 | — |
| 0 (this device) | K251091 | Lipids | Truvian Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2003 | 1 | 0 |
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 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 K232404 CHOLESTEROL; HDL-cholesterol…score 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K023642 | Piccolo Total Cholesterol Test SystemSummary page 5…Meets limitations of exemption per 21 CFR § 862.9 (c)(4) 3 Predicate Devices Primary Predicate Devices: Piccolo Total Cholesterol Test System (K023642) Secondary Predicate Devices: Piccolo Triglycerides Test System (K023639)… | 2003 |
| * | K023639 | Piccolo Triglycerides Test SystemSummary page 5…icate Devices: Piccolo Total Cholesterol Test System (K023642) Secondary Predicate Devices: Piccolo Triglycerides Test System (K023639) 1 4 Devi… | 2003 |
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?
- The line of descent spans 45 years and passes through 3 companies; a new generation was cleared every 22.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Lipids is part of the TruWellness Panel™ and is intended for use on the TruVerus™. Lipids (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Total Cholesterol (TChol) and Triglycerides (TRIG) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. From the TRIG determination, Very Low-Density Lipoprotein Cholesterol (VLDL) is calculated by the…
Read the full statement (131 words)
Lipids is part of the TruWellness Panel™ and is intended for use on the TruVerus™. Lipids (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Total Cholesterol (TChol) and Triglycerides (TRIG) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. From the TRIG determination, Very Low-Density Lipoprotein Cholesterol (VLDL) is calculated by the analyzer.
Lipids (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in the diagnosis and treatment of the following disorders in adults 18 years of age or older:
Total Cholesterol (TChol): Excess cholesterol in the blood and lipid and lipoprotein disorders.
Triglyceride (TRIG): Diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism; various endocrine disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251091: Lipids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251091
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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