Data / Medical devices / United States / Percussionaire Corp.
Percussionaire Corp.: FDA-registered device maker in Sandpoint, ID, United States, 2 510(k) clearances
Percussionaire Corp. is registered with the FDA (registration 3029845) in Sandpoint, ID, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 3, 1991. 8 recall events name it as the recalling firm (6 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3029845
- FEI number
- 1000524541
- Address
- 130 Mcghee RD Ste 109, Sandpoint, ID, United States, 83864
- Owner or operator
- PERCUSSIONAIRE CORP. (9029650)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 8, 2008
- Registered through
- 2026
- Brand names listed
- IPV Percussionator Family and Acc, LuMon(TM) System, P5-TEE, Phasitron Mouthpiece, VDR Sinusoidal Percussionator Famil
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Electrical Impedance Tomograph | QEB | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 3, 1991 | K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS | CBK | Substantially Equivalent | Percussionaire Corp. | accessdata.fda.gov |
| April 18, 1991 | K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES | NHJ | Substantially Equivalent | Percussionaire Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 18, 2026 | 99617 | Class II | Ongoing | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awar | accessdata.fda.gov |
| September 17, 2025 | 97374 | Class I | Ongoing | Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use | 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 acid | accessdata.fda.gov |
| December 23, 2024 | 95979 | Class I | Ongoing | VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT | 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. | accessdata.fda.gov |
| September 16, 2024 | 95436 | Class I | Ongoing | Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy | 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. | accessdata.fda.gov |
| August 21, 2024 | 95239 | Class I | Ongoing | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. | accessdata.fda.gov |
| December 12, 2023 | 93476 | Class I | Ongoing | High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 | 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 | accessdata.fda.gov |
| March 28, 2023 | 93648 | Class I | Ongoing | Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) | Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy. | accessdata.fda.gov |
| September 14, 2020 | 93192 | Class II | Completed | Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthpiece, Breathing
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Device, Positive Pressure Breathing, Intermittent
- All makers of Ventilator, Continuous, Facility Use
- All makers of Ventilatory Electrical Impedance Tomograph
Updated September 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.