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Sign in to claim this brandPercussionaire 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/
- —
- —
- [email protected]
- Phone
- +1 208 263 2549
- PRRC Contact
- Caroline Moller
- EUDAMED SRN
- US-MF-000036253
- FDA FEI Number
- —
- DUNS Number
- 603048778
Catalogue (69)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Percussionaire | A50095-1D | FDA UDI | Class II | Unknown |
| Percussionaire | F00012-HT2-RU | FDA UDI | Class II | Unknown |
| Percussionaire | F00002-C-FR | FDA UDI | Class II | Active |
| Percussionaire | Travel Air | FDA UDI | Class II | Unknown |
| Percussionaire | F00002-C | FDA UDI | Class II | Active |
| Percussionaire Oscillatron-1 Medical Respirator | K892886 | FDA 510(k) | Class II | Active |
| Vdr Sinusoidal Percusionator Family/Relate Access | K905235 | FDA 510(k) | Class II | Active |
| Percussionaire(r) Vdr-3 Imv Percus/Respir 1250 Min | K900313 | FDA 510(k) | Class II | Active |
| Percussionaire(r) Oscillatron-1 Percuss 1300 Min | K900314 | FDA 510(k) | Class II | Active |
| Txp Transporter Family And Related Accessories | K905234 | FDA 510(k) | Class II | Active |
| Rate Increase For Ippb/Ipv | K896586 | FDA 510(k) | Class I | Active |
| Percussionaire Txp Transporter/Respirators 750 Min | K900315 | FDA 510(k) | Class II | Active |
| Bird (ipv) Noncontinuous Ventilators | K895485 | FDA 510(k) | Class II | Active |
| Percussionaire Respirators (multiple) | K884832 | FDA 510(k) | Class II | Active |
| Bird (vdr) Sinusoidal Percussionators | K895486 | FDA 510(k) | Class II | Active |
| Ipv Percussionator Family & Related Accessories | K905236 | FDA 510(k) | Class II | Active |
| Phasitron® 5 With Unified Connector | P5UC | EUDAMEDFDA UDI | Class IIa | Active |
| IPV® In-Line Valve | P5-TEE | EUDAMEDFDA UDI | Class IIa | Active |
| Ipv 1 | S00065 | EUDAMEDFDA UDI | Class IIa | Active |
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. |