Cleared Traditional

MESI mTABLET SPIRO

K251777 · Mesi D.O.O. · Anesthesiology
Mar 2026
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K251777 is an FDA 510(k) clearance for the MESI mTABLET SPIRO, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Mesi D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on March 2, 2026, 265 days after receiving the submission on June 10, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K251777 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2025
Decision Date March 02, 2026
Days to Decision 265 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840