Percussionaire
IPV2-C, Spanish, Dual Gas, DISS-OXY, NIST-AIR, Spain (New variation; product line discontinued in EU before product launch.)
1manufacturer
40catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Percussionaire Corp., United States |
|---|---|
| FDA product code | NHJ |
| Device type | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K905236 |
| Record published | 2015-10-21 |
| Record revised | 2022-10-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case, case of 10, case of 5, box of 2, pack of 5, case of 2 |
| Distribution end date | 2025-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F00002-C | In distribution | |
| IPV1 | In distribution | |
| F00002-C | In distribution | |
| F00012 | In distribution | |
| F00002-C | In distribution | |
| F00002-C-FR | In distribution | |
| F00002-C | In distribution | |
| F00001-C | In distribution | |
| IPV1 | In distribution | |
| IPV1 | In distribution | |
| F00001-C | In distribution | |
| F00001-C-FR | In distribution | |
| P5 | In distribution | |
| F00002-C | In distribution | |
| P5 | In distribution | |
| P5-HC | In distribution | |
| F00002-C-FR | In distribution | |
| F00012 | Withdrawn | |
| A50110-HC-1D | Withdrawn | |
| P5-TH | Withdrawn | |
| A55108 | Withdrawn | |
| A50474-2D | Withdrawn | |
| F00012-HT | Withdrawn | |
| F00012-HT2-IL | Withdrawn | |
| A50110-HC-DUO | Withdrawn | |
| F00007-B | Withdrawn | |
| P5-TA | Withdrawn | |
| F00001-C | Withdrawn | |
| A50095-D | Withdrawn | |
| F00002-C | Withdrawn | |
| A50110-HC-OP A-D | Withdrawn | |
| F00012-HT2-RU | Withdrawn | |
| A50095-DUO | Withdrawn | |
| F00001-C-FR | Withdrawn | |
| A50095-1 | Withdrawn | |
| A50095-F | Withdrawn | |
| Travel Air | Withdrawn | |
| A50095-1D | Withdrawn | |
| A50110-HC-DM | Withdrawn | |
| A50110-HC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoughAssist | Respironics Inc. | 44 |
| The MetaNeb®System | Hill-Rom Services Pte, Ltd. | 14 |
| The VitalCough®System | Hill-Rom Services Pte, Ltd. | 10 |
| Synclara Cough System | Hill-Rom Services Pte, Ltd. | 10 |
| Volara System | Hill-Rom Services Pte, Ltd. | 9 |
| Vocsn Patient Breathing Package | Ventec Life Systems, Inc. | 7 |
| Clearo | Breas Medical, Inc. | 6 |
| Maximus System | Hill-Rom Services Pte, Ltd. | 6 |
| BiWaze Clear Dual Lumen Circuit With Face Mask – Adult Small | Abmrc LLC | 3 |
| BiWaze Cough Dual Lumen Circuit With Face Mask – Adult Large | Abmrc LLC | 3 |
| The Vest APX System | Hill-Rom Services Pte, Ltd. | 2 |
| Vortran PercussiveNEB 2.0 w/ Top Nebulizer Port | Vortran Medical Technology 1, Inc. | 1 |
Showing 12 of 32. All products under Device, Positive Pressure Breathing, Intermittent
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K905236 | 1991-04-18 |
| K895485 | 1989-10-30 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Percussionaire Corp. | 510(k) number | 2024-09-16 | Class I | Process control | 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 medicat | 43,830 devices |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.