Cleared Traditional

K251091 - Lipids

K251091 is an FDA 510(k) clearance for Lipids, manufactured by Truvian Health. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K251091 · Truvian Health · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
264d
Days
Class 1
Risk

K251091 is an FDA 510(k) clearance for the Lipids. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on December 30, 2025 after a review of 264 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Truvian Health devices

FDA 510(k) Submission Details - K251091

510(k) Number K251091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2025
Decision Date December 30, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 88d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHH Enzymatic Esterase--oxidase, Cholesterol

All 140
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K251091.
CHOLESTEROL
K232404 · Medicon Hellas S.A · Aug 2024
Cholesterol2
K203597 · Abbott Ireland Diagnostics Division · Jun 2022
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · Ortho-Clinical Diagnostics, Inc. · Mar 2019
Extended Lipid Panel Assay
K181373 · Laboratory Corporation of America Holdings · Oct 2018
Mission Lipid Panel Monitoring System
K180504 · ACON Laboratories, Inc. · Mar 2018
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406 · ACON Laboratories, Inc. · Jul 2017