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

FDA 510(k)

SANSA HSAT

K-Number: K250882 · 2025-10-29

Decision Date2025-10-29
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SANSA HSAT is the device name listed in this FDA 510(k) record. The listed applicant is Huxley Medical. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K250882. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANSA HSAT?

SANSA HSAT is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Huxley Medical. The 510(k) number is K250882.

When did SANSA HSAT receive FDA 510(k) clearance?

SANSA HSAT received FDA 510(k) clearance on 2025-10-29, under 510(k) number K250882.

Who is the listed applicant for SANSA HSAT?

The FDA 510(k) record lists Huxley Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANSA HSAT?

The FDA product code for SANSA HSAT is MNR.

Other records listing Huxley Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.