Intra-Pulmonary Percussive Vibration (Ipv) Devices
Intra-pulmonary percussive vibration (IPV) devices are respiratory therapy devices intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways, facilitating airway clearance in patients with conditions such as cystic fibrosis, chronic obstructive pulmonary disease, or other conditions causing mucus retention. They are classified as FDA Class II (510(k) required) under regulation 868.5665 in the Anesthesiology specialty, with product code SDT. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SDT
- Device Class
- FDA class 2
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241091 | SIMEOX 200 Airway Clearance Device | Dec 23, 2024 | Substantially Equivalent | Inogen, Inc. |
| K133057 | VIBRALUNG ACOUSTICAL PERCUSSOR | May 23, 2014 | Substantially Equivalent | Westmed, Inc. |
| K122111 | RESPIRONICS SIMPLYCLEAR DEVICE | Dec 31, 2012 | Substantially Equivalent | Respironics, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.