Cleared Traditional

K241091 - SIMEOX 200 Airway Clearance Device (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K241091 is an FDA 510(k) clearance for the SIMEOX 200 Airway Clearance Device. Classified as Intra-pulmonary Percussive Vibration (ipv) Devices (product code SDT), Class II - Special Controls.

Submitted by Inogen, Inc. (Goleta, US). The FDA issued a Cleared decision on December 23, 2024 after a review of 245 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inogen, Inc. devices

Submission Details

510(k) Number K241091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 139d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SDT Intra-pulmonary Percussive Vibration (ipv) Devices
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Nilo Medical Consulting Group
Michael Nilo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.