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Percussionaire Corporation

United States·US-MF-000036253

Last updated May 27, 2026

What Percussionaire Corporation makes

The company designs and manufactures portable and stationary pneumatic high-frequency ventilators, including models with integrated respiration monitoring capabilities. Their product line also includes single-use ventilator breathing circuits, which are intended for use with these devices. These ventilators are primarily pneumatic systems, suitable for both mobile and fixed clinical environments.

The ventilators and associated components are classified as Class II or Class IIa medical devices under regulatory frameworks. They are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Percussionaire Corporation manufacture?

Percussionaire Corporation specializes in designing and manufacturing portable and stationary pneumatic high-frequency ventilators. Their product line includes both standalone ventilators and models with integrated respiration monitors. Additionally, they produce single-use ventilator breathing circuits, which are intended for use specifically with their ventilator systems. These devices are primarily pneumatic, meaning they rely on compressed air to deliver ventilation, and are suited for both mobile and fixed clinical settings.

Where is Percussionaire Corporation based?

Percussionaire Corporation is headquartered in the United States. While the exact location isn’t specified, the company’s regulatory listings confirm its operational base is within the country.

Which regulatory registries list Percussionaire Corporation’s devices?

Percussionaire Corporation’s devices are listed in two key regulatory databases: the EU’s EUDAMED system and the FDA’s Unique Device Identifier (UDI) database. These registries track medical devices authorized for use in the European Union and the United States, respectively, ensuring transparency and traceability for healthcare providers and regulators.

How are Percussionaire Corporation’s ventilators classified under medical device regulations?

Percussionaire’s ventilators and associated components fall under Class II or Class IIa classifications in regulatory frameworks. This classification is typically assigned to devices that pose moderate risks and require special controls beyond general good manufacturing practices to ensure safety and effectiveness. The specific class depends on factors like the device’s intended use, potential risks, and the body’s interaction with the product.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 130, McGhee Rd., Sandpoint, United States
Website: www.sentec.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 208 263 2549
PRRC Contact: Caroline Moller
EUDAMED SRN: US-MF-000036253
FDA FEI Number: —
DUNS Number: 603048778

Catalogue (69)

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Device	Model / Reference	Registries	Class	Status
Percussionaire	F00001-C-FR	FDA UDI	Class II	Active
Percussionaire	F00029-1	FDA UDI	Class II	Active
Percussionaire	A50094-D	FDA UDI	Class II	Active
Percussionaire	IPV1	FDA UDI	Class II	Active
Percussionaire	A50110-HC-DUO	FDA UDI	Class II	Unknown
Percussionaire	F00038-2FR	FDA UDI	Class II	Unknown
Percussionaire	F00002-C	FDA UDI	Class II	Active
Percussionaire	A50095-1	FDA UDI	Class II	Unknown
Percussionaire	F00038-2	FDA UDI	Class II	Unknown
Percussionaire	A55108	FDA UDI	Class II	Unknown
Percussionaire	F00012	FDA UDI	Class II	Active
Percussionaire	F00038-1	FDA UDI	Class II	Unknown
Percussionaire	A50096-D	FDA UDI	Class II	Unknown
Percussionaire	A50095-DUO	FDA UDI	Class II	Unknown
Percussionaire	P5-TA	FDA UDI	Class II	Unknown
Percussionaire	A50474-2D	FDA UDI	Class II	Unknown
Percussionaire	A50110-HC-DM	FDA UDI	Class II	Unknown
Percussionaire	F00012-HT	FDA UDI	Class II	Unknown
Percussionaire	F00008-1	FDA UDI	Class II	Active
Percussionaire	F00007-1	FDA UDI	Class II	Active
Percussionaire	F00001-C-FR	FDA UDI	Class II	Unknown
Percussionaire	F00008-1FR	FDA UDI	Class II	Unknown
Percussionaire	IPV1	FDA UDI	Class II	Active
Percussionaire	F00007-1	FDA UDI	Class II	Active
Percussionaire	S20020	FDA UDI	Class II	Active
Percussionaire	A50095-F	FDA UDI	Class II	Unknown
Percussionaire	F00001-C	FDA UDI	Class II	Active
Percussionaire	F00002-C	FDA UDI	Class II	Unknown
Percussionaire	A50095-D	FDA UDI	Class II	Unknown
Percussionaire	F00002-C-FR	FDA UDI	Class II	Active
Percussionaire	A50110-HC-1D	FDA UDI	Class II	Unknown
Percussionaire	F00001-C	FDA UDI	Class II	Unknown
Percussionaire	F00002-C	FDA UDI	Class II	Active
Percussionaire	P5-HC	FDA UDI	Class II	Active
Percussionaire	F00038-1FR	FDA UDI	Class II	Unknown
Percussionaire	F00002-C	FDA UDI	Class II	Active
Percussionaire	P5	FDA UDI	Class II	Active
Percussionaire	F00008-1	FDA UDI	Class II	Active
Percussionaire	A50110-HC-OP A-D	FDA UDI	Class II	Unknown
Percussionaire	A50606-TXP	FDA UDI	Class II	Unknown
Percussionaire	F00002-C	FDA UDI	Class II	Active
Percussionaire	F00012	FDA UDI	Class II	Unknown
Percussionaire	P5-TH	FDA UDI	Class II	Unknown
Percussionaire	A50110-HC	FDA UDI	Class II	Unknown
Percussionaire	F00007-B	FDA UDI	Class II	Unknown
Percussionaire	TXP5	FDA UDI	Class II	Unknown
Percussionaire	F00029-1	FDA UDI	Class II	Active
Percussionaire	A50605-D	FDA UDI	Class II	Active
Percussionaire	F00001-C	FDA UDI	Class II	Active
Percussionaire	F00012-HT2-IL	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Percussionaire Corporation has eight FDA recall records initiated between September 14, 2020, and September 17, 2025. The records include completed, open, and classified statuses, with reasons involving assembly errors in breathing circuits (e.g., incorrect attachment points, pressure output issues), discolored fluid in nebulizer cups due to chemical reactions, waveform analyzer screen freezes requiring microprocessor upgrades, venturi component malfunctions affecting ventilation, and labeling updates for in-line valves—including restrictions on use in neonates and infants and instructions for cap removal prior to therapy.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 17, 2025	Z-0031-2026	—	open, classified	IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
Dec 23, 2024	Z-0960-2025	—	open, classified	Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
Sep 16, 2024	Z-0208-2025	—	open, classified	As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.
Aug 21, 2024	Z-3207-2024	—	open, classified	Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Aug 21, 2024	Z-3208-2024	—	open, classified	Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Dec 12, 2023	Z-0637-2024	—	open, classified	Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
Mar 28, 2023	Z-0693-2024	—	open, classified	Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Sep 14, 2020	Z-0259-2024	—	completed	Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.