Percussionaire Corp.
Sandpoint, ID, US
PERCUSSIONAIRE CORP. appears in FDA device records in Sandpoint, ID. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Percussionaire Corp. between 1989 and 1991. The busiest year on record is 1989, with 4. The most recent is 1991, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 4 |
| 1990 | 4 |
| 1991 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K905234 | TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES | CBK | Substantially Equivalent | |
| K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS | CBK | Substantially Equivalent | |
| K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES | NHJ | Substantially Equivalent | |
| K900315 | PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN | CBK | Substantially Equivalent for Some Indications | |
| K900314 | PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN | CBK | Substantially Equivalent for Some Indications | |
| K900313 | PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN | CBK | Substantially Equivalent | |
| K896586 | RATE INCREASE FOR IPPB/IPV | DZD | Substantially Equivalent | |
| K895485 | BIRD (IPV) NONCONTINUOUS VENTILATORS | NHJ | Substantially Equivalent | |
| K892886 | PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR | CBK | Substantially Equivalent | |
| K895486 | BIRD (VDR) SINUSOIDAL PERCUSSIONATORS | CBK | Substantially Equivalent | |
| K884832 | PERCUSSIONAIRE RESPIRATORS (MULTIPLE) | CBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3029845 | 1000524541 | PERCUSSIONAIRE CORP. | 130 MCGHEE RD STE 109, SANDPOINT, ID 83864 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0031-2026 | 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 acidosis, hypoxemia, or respiratory failure. | Class I | Open, Classified | |
| Z-0960-2025 | 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 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients | 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. | Class I | Open, Classified | |
| Z-0208-2025 | 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. | Class I | Open, Classified | |
| Z-3208-2024 | Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, 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. | Class I | Open, Classified | |
| Z-3207-2024 | 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. | Class I | Open, Classified | |
| Z-0637-2024 | 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 | Class I | Open, Classified | |
| Z-0693-2024 | 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. | Class I | Open, Classified | |
| Z-0259-2024 | 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. | Class II | Completed |
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Data as of , FDA export datePage updated Source: openFDA, public domain