Company ยท US
Percussionaire Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1991. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
15recalls (7 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 1991 | K905234 | TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES Percussionaire Corp. | CBK |
| May 3, 1991 | K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS Percussionaire Corp. | CBK |
| Apr 18, 1991 | K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES Percussionaire Corp. | NHJ |
| Oct 26, 1990 | K900315 | PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN Percussionaire Corp. | CBK |
| Oct 26, 1990 | K900314 | PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN Percussionaire Corp. | CBK |
| Oct 26, 1990 | K900313 | PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN Percussionaire Corp. | CBK |
| Jan 9, 1990 | K896586 | RATE INCREASE FOR IPPB/IPV Percussionaire Corp. | DZD |
| Oct 30, 1989 | K895485 | BIRD (IPV) NONCONTINUOUS VENTILATORS Percussionaire Corp. | NHJ |
| Oct 27, 1989 | K892886 | PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR Percussionaire Corp. | CBK |
| Oct 13, 1989 | K895486 | BIRD (VDR) SINUSOIDAL PERCUSSIONATORS Percussionaire Corp. | CBK |
| Sep 14, 1989 | K884832 | PERCUSSIONAIRE RESPIRATORS (MULTIPLE) Percussionaire Corp. | CBK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation In-Line Valve, Product Number: P5-TEE Open, Classified |
MOD | None listed |
| Sep 28, 2026 | Percussionaire Corporation 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 Open, Classified |
NHJ | None listed |
| Oct 14, 2025 | Percussionaire Corporation 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 Open, Classified |
BZO | None listed |
| Jan 23, 2025 | Percussionaire Corporation 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 PA Open, Classified |
CBK | K905235 |
| Oct 30, 2024 | Percussionaire Corporation Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy Open, Classified |
NHJ | K905236 |
| Sep 27, 2024 | Percussionaire Corporation Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve Open, Classified |
BZO | None listed |
| Sep 27, 2024 | Percussionaire Corporation Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve Open, Classified |
BZO | None listed |
| Jan 17, 2024 | Percussionaire Corporation High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 Open, Classified |
CBK | K905234 |
| Jan 17, 2024 | Percussionaire Corporation Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) Open, Classified |
CBK | K905235 |
| Nov 7, 2023 | Percussionaire Corporation Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. Completed |
CBK | K905235 |