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Percussionaire Respirators (Multiple)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K884832

by Percussionaire Corp.

Identifiers

510(k) Number
K884832 FDA 510(k)
FDA Product Code
CBK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5895 FDA 510(k)
Regulation Number
868.5895 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Percussionaire Respirators are electronic pressure volume cycled devices or ventilators that provide Intrapulmonary Percussive Ventilation®, Volumetric Diffusive Respiration® and Percussionators®. These devices function as therapeutic work-horses for cardiopulmonary ventilation and circulatory lung recruitment.

The Percussionaire Respirators are supplied for facility use and are classified as Class II medical devices. They are authorized under FDA 510K clearance with product code CBK and are intended for use in anesthesiology settings. The devices are manufactured by Percussionaire Corp. in Sandpoint, Idaho.

Frequently asked questions

What are Percussionaire Respirators used for?

Percussionaire Respirators are electronic pressure volume cycled devices that provide Intrapulmonary Percussive Ventilation®, Volumetric Diffusive Respiration® and Percussionators®. They function as therapeutic work-horses for cardiopulmonary ventilation and circulatory lung recruitment in anesthesiology settings.

How are Percussionaire Respirators supplied and classified?

The Percussionaire Respirators are supplied for facility use and are classified as Class II medical devices. They are manufactured by Percussionaire Corp. in Sandpoint, Idaho and are intended for use in anesthesiology settings.

What is the regulatory status of Percussionaire Respirators?

Percussionaire Respirators are authorized under FDA 510K clearance with product code CBK. They have been determined to be substantially equivalent to other devices in this category, with the first clearance received in 1989.

Are there different models of Percussionaire Respirators available?

The device data indicates multiple models of Percussionaire Respirators exist, as evidenced by the numerous FEI numbers and registration numbers listed in the specifications. However, specific model numbers or variations are not detailed in the provided information.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Percussionaire Corporation - Sandpoint, Idaho (ID) @ MedicRegister.com, PDF VDR-4 System - Sentec, Percussionaire, 130 McGhee Road, Suite 109, Sandpoint, ID (2026)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Percussionaire Corp.

Sources (1)

  • FDA 510(k) K884832 24 fields · synced Sep 26, 2026