Cleared Traditional

SANSA HSAT

K252497 · Huxley Medical · Anesthesiology
Dec 2025
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K252497 is an FDA 510(k) clearance for the SANSA HSAT, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Huxley Medical (Atlanta, US). The FDA issued a Cleared decision on December 10, 2025, 124 days after receiving the submission on August 8, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K252497 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2025
Decision Date December 10, 2025
Days to Decision 124 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375