Cleared Traditional

SIMEOX 200 Airway Clearance Device

K241091 · Inogen, Inc. · Anesthesiology
Dec 2024
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K241091 is an FDA 510(k) clearance for the SIMEOX 200 Airway Clearance Device, a Intra-pulmonary Percussive Vibration (ipv) Devices (Class II — Special Controls, product code SDT), submitted by Inogen, Inc. (Goleta, US). The FDA issued a Cleared decision on December 23, 2024, 245 days after receiving the submission on April 22, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5665.

Submission Details

510(k) Number K241091 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2024
Decision Date December 23, 2024
Days to Decision 245 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code SDT — Intra-pulmonary Percussive Vibration (ipv) Devices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5665
Definition It Is Intended To Mobilize Mucus Using Vibration And/or Pressure Delivered Through A Mouthpiece Into The Airways.