Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5665](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5665) → SDT — Intra-Pulmonary Percussive Vibration (Ipv) Devices

# SDT · Intra-Pulmonary Percussive Vibration (Ipv) Devices

_Anesthesiology · 21 CFR 868.5665 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SDT

## Overview

- **Product Code:** SDT
- **Device Name:** Intra-Pulmonary Percussive Vibration (Ipv) Devices
- **Regulation:** [21 CFR 868.5665](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5665)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K241091](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SDT/K241091.md) | SIMEOX 200 Airway Clearance Device | Inogen, Inc. | Dec 23, 2024 | SESE |
| [K133057](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SDT/K133057.md) | VIBRALUNG ACOUSTICAL PERCUSSOR | Westmed, Inc. | May 23, 2014 | SESE |
| [K122111](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SDT/K122111.md) | RESPIRONICS SIMPLYCLEAR DEVICE | Respironics, Inc. | Dec 31, 2012 | SESE |

## Top Applicants

- Inogen, Inc. — 1 clearance
- Respironics, Inc. — 1 clearance
- Westmed, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SDT](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SDT)

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