FDA product code SDT: Intra-Pulmonary Percussive Vibration (Ipv) Devices
SDT is the FDA product code for intra-pulmonary percussive vibration (ipv) devices. It is a Class II device, regulated under 21 CFR 868.5665 and reviewed by the Anesthesiology panel. FDA has cleared 3 510(k) submissions under SDT, 1 in the last five years, from 3 different applicants. The average 510(k) review took 217 days (median 238); 245 days on average over the last three years.
Definition
It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.
Classification
| Field | Value |
|---|---|
| Device name | Intra-Pulmonary Percussive Vibration (Ipv) Devices |
| Device class | Class II |
| Regulation | 21 CFR 868.5665 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for SDT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 245 |
Compare with all 510(k) review times · Search every SDT clearance
Top SDT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inogen, Inc. | 1 | 2024-12-23 |
| Westmed, Inc. | 1 | 2014-05-23 |
| Respironics, Inc. | 1 | 2012-12-31 |
Most recent SDT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241091 | Inogen, Inc. | SIMEOX 200 Airway Clearance Device | 2024-12-23 | 245 |
| K133057 | Westmed, Inc. | VIBRALUNG ACOUSTICAL PERCUSSOR | 2014-05-23 | 238 |
| K122111 | Respironics, Inc. | RESPIRONICS SIMPLYCLEAR DEVICE | 2012-12-31 | 167 |
Recalls for SDT devices
openFDA lists no recalls for product code SDT.
Frequently asked questions
What is FDA product code SDT?
SDT is the FDA product code for intra-pulmonary percussive vibration (ipv) devices. It is a Class II device, regulated under 21 CFR 868.5665 and reviewed by the Anesthesiology panel.
What device class is SDT?
Class II, regulation 21 CFR 868.5665. Typical premarket route: 510(k).
How long does a 510(k) take for product code SDT?
Across 3 cleared submissions the average was 217 days from receipt to decision (median 238).
Which companies have the most SDT clearances?
Inogen, Inc. (1); Westmed, Inc. (1); Respironics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SDT
- Run a recall and safety report across every SDT manufacturer
- Watch product code SDT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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