# K241091: SIMEOX 200 Airway Clearance Device

- Pathway: 510(k) (Traditional)
- Applicant: Inogen, Inc.
- Decided: Dec 23, 2024 after 245 days
- Product code: SDT (Intra-Pulmonary Percussive Vibration (Ipv) Devices)
- Device class: 2
- Regulation: 21 CFR 868.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K884098 (1988). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203209: AirPhysio Positive Expiratory Pressure (PEP) Device, Airphysio Pty, Ltd. (2021) Summary page 5.
- K122111: Respironics Simplyclear Device, Respironics, Inc. (2012) Summary page 5.

## Indications for use
The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough. SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.

Source page: https://510kreport.com/device/K241091
Methodology: https://510kreport.com/methodology