Class Class II
SIMEOX 200 Airway Clearance Device (K241091)
Description
SIMEOX 200 Airway Clearance Device by Inogen, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241091
Clearance Date2024-12-23
Clearance TypeTraditional
Product CodeSDT
Regulation Number868.5665
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241091
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SIMEOX 200 Airway Clearance Device (K241091) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | 2021 |
| K122111 | RESPIRONICS SIMPLYCLEAR DEVICE | Respironics, Inc. | 2012 |
Trace the full predicate network for K241091
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.