SDT · Class II · 21 CFR 868.5665

FDA Product Code SDT: Intra-pulmonary Percussive Vibration (ipv) Devices

It Is Intended To Mobilize Mucus Using Vibration And/or Pressure Delivered Through A Mouthpiece Into The Airways.

Leading manufacturers include Inogen, Inc..

3
Total
3
Cleared
217d
Avg days
2012
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 245d recently vs 203d historically

FDA 510(k) Cleared Intra-pulmonary Percussive Vibration (ipv) Devices Devices (Product Code SDT)

3 devices
1–3 of 3
Cleared Dec 23, 2024
SIMEOX 200 Airway Clearance Device
K241091
Inogen, Inc.
Anesthesiology · 245d

About Product Code SDT - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code SDT since 2012, with 3 receiving FDA clearance (average review time: 217 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under SDT have taken an average of 245 days to reach a decision - up from 203 days historically. Manufacturers should account for longer review timelines in current project planning.

SDT devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →