Cleared Traditional

HeroTracker Sense

K250022 · Voluntis · Anesthesiology

Jun 2025

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K250022 is an FDA 510(k) clearance for the HeroTracker Sense, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Voluntis (Paris, FR). The FDA issued a Cleared decision on June 30, 2025, 178 days after receiving the submission on January 3, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K250022 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 2025
Decision Date	June 30, 2025
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF