Cleared Traditional

Aluna 2

K232588 · Knox Medical Diagnostics · Anesthesiology

Nov 2024

Decision

458d

Days

Class 2

Risk

About This 510(k) Submission

K232588 is an FDA 510(k) clearance for the Aluna 2, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Knox Medical Diagnostics (San Francisco, US). The FDA issued a Cleared decision on November 25, 2024, 458 days after receiving the submission on August 25, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number	K232588 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2023
Decision Date	November 25, 2024
Days to Decision	458 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF