SDT
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intra-Pulmonary Percussive Vibration (Ipv) Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5665
- Medical specialty
- Anesthesiology
- FDA definition
- It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SIMEOX 200 Airway Clearance Device (K241091) | Inogen, Inc. | 2024-12-23 |
| VIBRALUNG ACOUSTICAL PERCUSSOR (K133057) | Westmed, Inc. | 2014-05-23 |
| RESPIRONICS SIMPLYCLEAR DEVICE (K122111) | Respironics, Inc. | 2012-12-31 |
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Every clearance here is in the API, with alerts when new ones post.