SIMEOX 200 Airway Clearance Device

FDA 510(k) K241091 · Inogen, Inc.

Substantially Equivalent

510(k) numberK241091

Submission

Device name
SIMEOX 200 Airway Clearance Device
Applicant
Inogen, Inc.
Goleta, CA, US
Received
April 22, 2024
Decision date
December 23, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SDT – Intra-Pulmonary Percussive Vibration (Ipv) Devices
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5665
Specialty
Anesthesiology

It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.

Other 510(k)s with product code SDT

510(k)DeviceApplicantDecision
K133057Vibralung Acoustical PercussorSDT · Traditional Westmed, Inc.05/23/2014SE
K122111Respironics Simplyclear DeviceSDT · Abbreviated Respironics, Inc.12/31/2012SE

More from Respironics, Inc.

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K230052Inogen Rove 6CAW · Traditional 06/30/2023SE
K222086Inogen Rove 4 Portable Oxygen ConcentratorCAW · Traditional 12/09/2022SE
K132489Inogen at Home Oxygen Concentrator (Aka Inogen at Home)CAW · Traditional 06/20/2014SE
K032818Inogen One Oxygen ConcentratorCAW · Traditional 05/13/2004SE

Questions and answers

When was SIMEOX 200 Airway Clearance Device cleared by the FDA?

SIMEOX 200 Airway Clearance Device (K241091) received a 510(k) decision of Substantially Equivalent on December 23, 2024, 245 days after the submission was received.

What is the product code of K241091?

The FDA product code is SDT – Intra-Pulmonary Percussive Vibration (Ipv) Devices, a Class II (moderate risk) device regulated under 21 CFR 868.5665.