Cleared Traditional

Makani Science? Respiration Monitoring System

K233953 · Makani Science, Inc. · Anesthesiology

Mar 2025

Decision

469d

Days

Class 2

Risk

About This 510(k) Submission

K233953 is an FDA 510(k) clearance for the Makani Science? Respiration Monitoring System, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Makani Science, Inc. (Irvine, US). The FDA issued a Cleared decision on March 28, 2025, 469 days after receiving the submission on December 15, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K233953 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2023
Decision Date	March 28, 2025
Days to Decision	469 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF