Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Core Metabolic

K-Number: K251157 · 2026-01-09

Decision Date2026-01-09
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Core Metabolic is a medical device manufactured by Truvian Health. It received FDA 510(k) clearance on 2026-01-09 under approval number K251157. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Core Metabolic?

Core Metabolic is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by Truvian Health. The 510(k) number is K251157.

When was Core Metabolic approved by the FDA?

Core Metabolic received FDA 510(k) clearance on 2026-01-09, under approval number K251157.

What company makes Core Metabolic?

Core Metabolic is manufactured by Truvian Health.

What is the FDA product code for Core Metabolic?

The FDA product code for Core Metabolic is CIX.

Other Devices by Truvian Health

Related Devices (Code: CIX)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.