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SDT — Intra-Pulmonary Percussive Vibration (Ipv) Devices Class II

FDA Device Classification

Classification Details

Product Code
SDT
Device Class
Class II
Regulation Number
868.5665
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241091inogenSIMEOX 200 Airway Clearance DeviceDecember 23, 2024
K133057westmedVIBRALUNG ACOUSTICAL PERCUSSORMay 23, 2014
K122111respironicsRESPIRONICS SIMPLYCLEAR DEVICEDecember 31, 2012