K241091 is an FDA 510(k) clearance for the SIMEOX 200 Airway Clearance Device. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5665. It Is Intended To Mobilize Mucus Using Vibration And/or Pressure Delivered Through A Mouthpiece Into The Airways..
| 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 |
| 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. |