Cleared Traditional

SANSA HSAT

K250882 · Huxley Medical · Cardiovascular
Oct 2025
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K250882 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 October 29, 2025, 219 days after receiving the submission on March 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K250882 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2025
Decision Date October 29, 2025
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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