Skip to content

Pneumo Pulssor III

by Strom Corp.

510(k) K821570

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821570 Date3 Jun 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BYI
Device Class
Class II
Regulation
21 CFR Part 868.5665
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pneumo Pulssor III is a powered-electric percussor device, classified as a Class II medical device. It is designed to deliver percussive therapy by generating rapid, rhythmic air pulses to assist in loosening and mobilizing secretions in the respiratory tract, aiding in patient comfort and clearance of airway obstructions. This device operates through a pneumatic mechanism to provide mechanical percussion, commonly used in clinical settings for respiratory care.

The Pneumo Pulssor III is intended for use in clinical environments, such as operating rooms or anesthesia suites, where respiratory support is required. It is supplied as a reusable device and is regulated under FDA 510(k) clearance (K821570) with a product code of BYI. The device falls under the regulatory category 868.5665 and was granted Substantially Equivalent status by the FDA’s Anesthesiology Advisory Committee in 1982. No specific sterility or MRI safety information is provided in the available data.

Other devices from Strom Corp.