Cleared Special

SANSA HSAT

K244027 · Huxley Medical · Anesthesiology
Jan 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K244027 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 January 28, 2025, 29 days after receiving the submission on December 30, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K244027 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2024
Decision Date January 28, 2025
Days to Decision 29 days
Submission Type Special
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